<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252145</url>
  </required_header>
  <id_info>
    <org_study_id>P0518095</org_study_id>
    <secondary_id>NCI-2018-00009</secondary_id>
    <secondary_id>16802</secondary_id>
    <nct_id>NCT03252145</nct_id>
  </id_info>
  <brief_title>Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device</brief_title>
  <official_title>Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Foundation for Physical Therapy, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a&#xD;
      negative pressure massage device (intervention group), to the standard manual lymph drainage&#xD;
      massage (control group), in breast cancer patients with chronic upper extremity lymphedema.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphedema (LE) is a protein-rich interstitial swelling caused by reduced lymph transport&#xD;
      secondary to lymphatic system damage from cancer treatments. 1 in 5 women will develop LE&#xD;
      following breast cancer treatment. These women have greater restrictions in activity and&#xD;
      poorer quality of life (QOL) and are more prone to cellulitis than women without LE. LE is&#xD;
      incurable and progressive. Persistent lymph stasis creates a condition of chronic&#xD;
      inflammation that contributes to fibrosis and fatty deposition in the subcutis of the&#xD;
      affected limb. The fibro-adipose changes associated with chronic LE make it less responsive&#xD;
      to treatments that primarily target limb volume. Treatments are needed that can improve these&#xD;
      skin and subcutaneous tissues changes, as well as reduce limb volume.&#xD;
&#xD;
      This 4 to 6 week randomized controlled pilot feasibility study will enroll 80 women with&#xD;
      chronic arm LE, and will evaluate a novel negative pressure massage device that mobilizes&#xD;
      skin and subcutaneous tissue. This negative pressure treatment provides vertical (lifting)&#xD;
      and horizontal stretching of the skin and underlying fascial structures, which increases the&#xD;
      subcutaneous space for lymphatic circulation, improves lymph flow, and has the potential to&#xD;
      decrease fibrosis. This treatment will be compared to the standard of care massage: manual&#xD;
      lymphatic drainage. Women will be randomly assigned to either the negative pressure massage&#xD;
      device (intervention group), to the standard manual lymph drainage massage (control group)&#xD;
&#xD;
      Objectives: To evaluate recruitment and retention rates; to determine rates of adverse&#xD;
      events; and to determine effect sizes for limb volume, tissue induration; and patient&#xD;
      reported outcomes of arm function, QOL, and body image in response to treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment Rates</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Completed All Study Visits</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Limb Volume</measure>
    <time_frame>At Baseline</time_frame>
    <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Limb Volume</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Lymphedema Index (L-DEX®) Ratio Scores</measure>
    <time_frame>At Baseline</time_frame>
    <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean L-DEX® Scores</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Skin Induration Score</measure>
    <time_frame>At Baseline</time_frame>
    <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Skin Induration Score</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Degrees of Shoulder Range of Motion</measure>
    <time_frame>At Baseline</time_frame>
    <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Degrees of Shoulder Range of Motion</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Grip Score</measure>
    <time_frame>At Baseline</time_frame>
    <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilogram of force) calculated. A higher score indicates a greater grip strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Grip Score</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilograms of force) calculated. A higher score indicates a greater grip strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Karnofsky Performance Status (KPS) Score</measure>
    <time_frame>At Baseline</time_frame>
    <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Karnofsky Performance Status (KPS) Score</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</measure>
    <time_frame>At Baseline</time_frame>
    <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</measure>
    <time_frame>4 weeks</time_frame>
    <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Norman Questionnaire (NQ) Scores</measure>
    <time_frame>At Baseline</time_frame>
    <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Norman Questionnaire (NQ) Scores</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Norman Questionnaire (NQ) Scores</measure>
    <time_frame>At 4 months</time_frame>
    <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</measure>
    <time_frame>At Baseline</time_frame>
    <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</measure>
    <time_frame>At Baseline</time_frame>
    <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</measure>
    <time_frame>At Baseline</time_frame>
    <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</measure>
    <time_frame>At Baseline</time_frame>
    <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Body Image Scale (BIS) Score</measure>
    <time_frame>At baseline</time_frame>
    <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Body Image Scale (BIS) Score</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (FACIT-TSG- Version 4). The FACIT-TSG is a copyrighted 8-item questionnaire, with each item score ranging from 0 (&quot;not at all&quot;) to 4 (&quot;very much&quot;). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Lymphedema, Secondary</condition>
  <condition>Lymphedema of Upper Limb</condition>
  <arm_group>
    <arm_group_label>Negative Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Lymph Drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PhysioTouch</intervention_name>
    <description>The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
    <arm_group_label>Negative Pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual Lymph Drainage (MLD)</intervention_name>
    <description>MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
    <arm_group_label>Manual Lymph Drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
        To be included women must be:&#xD;
&#xD;
        Be over 18 years of age;&#xD;
&#xD;
        Have had cancer treatment that included a surgical procedure, radiation therapy (RT),&#xD;
        and/or chemotherapy (CTX);&#xD;
&#xD;
        Have completed active cancer treatment at least 1 year prior to study enrollment;&#xD;
&#xD;
        Have been diagnosed with lymphedema (LE) at least one year prior to study enrollment;&#xD;
&#xD;
        Have arm lymphedema on one side only;&#xD;
&#xD;
        Have confirmed LE based on bioimpedance measurements with an L-Dex® score of &gt;7.1 (note -&#xD;
        this is very mild lymphedema);&#xD;
&#xD;
        Have stable arm LE. LE will be considered &quot;stable&quot; if during the 3 months prior to study&#xD;
        enrollment there was no arm infection requiring antibiotics, no change in ability to&#xD;
        perform activities of daily living related to LE, and no subjective report of significant&#xD;
        persistent changes in limb volume;&#xD;
&#xD;
        Be mentally and physically able to participate in the study;&#xD;
&#xD;
        Be able to attend the sessions at the University of California, San Francisco (UCSF)&#xD;
        Parnassus campus;&#xD;
&#xD;
        Read and understand English;&#xD;
&#xD;
        Be able to understand a written informed consent document and the willingness to sign it&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
        Women cannot have:&#xD;
&#xD;
          -  Bilateral upper extremity LE;&#xD;
&#xD;
          -  Current infection or lymphangitis involving the affected arm;&#xD;
&#xD;
          -  Current recurrence of their breast cancer (BC) (local or distant)&#xD;
&#xD;
          -  Pre-existing LE prior to their BC diagnosis;&#xD;
&#xD;
          -  A condition that precludes measurement of LE using Bioimpedance Spectroscopy (BIS),&#xD;
             including pregnancy;&#xD;
&#xD;
          -  Current venous thrombosis in either upper extremity or be on current anticoagulant&#xD;
             therapy;&#xD;
&#xD;
          -  Extremity edema due to heart failure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betty Smoot, DPTSc, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>November 13, 2020</results_first_submitted>
  <results_first_submitted_qc>December 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2021</results_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03252145/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03252145/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from a University of California, San Francisco 5-year cross-sectional study (CA187160). In addition, flyers were made available to participants at lymphedema and breast cancer conferences and patient symposia. Community collaborators (breast surgeons, lymphedema specialists, support group leaders) were also sent informational and recruitment materials related to the study.</recruitment_details>
      <pre_assignment_details>Of the 130 who expressed interest in the study, only 28 met all inclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Manual Lymph Drainage</title>
          <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
        </group>
        <group group_id="P2">
          <title>Negative Pressure</title>
          <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Complicating Disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Manual Lymph Drainage</title>
          <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
        </group>
        <group group_id="B2">
          <title>Negative Pressure</title>
          <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>30-39 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80-89 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Recruitment Rates</title>
        <description>The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Recruitment Rates</title>
          <description>The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.</description>
          <units>rate of recruitment</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5"/>
                    <measurement group_id="O2" value="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Completed All Study Visits</title>
        <description>Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Completed All Study Visits</title>
          <description>Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.6"/>
                    <measurement group_id="O2" value="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Limb Volume</title>
        <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
        <time_frame>At Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Limb Volume</title>
          <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383.32" spread="324.74"/>
                    <measurement group_id="O2" value="622.17" spread="396.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.096</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Limb Volume</title>
        <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Limb Volume</title>
          <description>Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)</description>
          <units>ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352.66" spread="317.74"/>
                    <measurement group_id="O2" value="512.98" spread="332.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Lymphedema Index (L-DEX®) Ratio Scores</title>
        <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
        <time_frame>At Baseline</time_frame>
        <population>The range of L-DEX ratio scores on our study at baseline were 0.1 - 74.20.</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Lymphedema Index (L-DEX®) Ratio Scores</title>
          <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
          <population>The range of L-DEX ratio scores on our study at baseline were 0.1 - 74.20.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.09" spread="20.87"/>
                    <measurement group_id="O2" value="34.16" spread="24.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.096</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean L-DEX® Scores</title>
        <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>The range of L-DEX ratio scores on our study at 4 weeks were -2.85 - 77.50.</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean L-DEX® Scores</title>
          <description>Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms &amp; 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.</description>
          <population>The range of L-DEX ratio scores on our study at 4 weeks were -2.85 - 77.50.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.30" spread="22.23"/>
                    <measurement group_id="O2" value="30.09" spread="22.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Skin Induration Score</title>
        <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
        <time_frame>At Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Skin Induration Score</title>
          <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.077" spread="0.023"/>
                    <measurement group_id="O2" value="0.072" spread="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.552</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Skin Induration Score</title>
        <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Skin Induration Score</title>
          <description>The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.</description>
          <units>Newtons</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.069" spread="0.017"/>
                    <measurement group_id="O2" value="0.065" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.498</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Degrees of Shoulder Range of Motion</title>
        <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
        <time_frame>At Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Degrees of Shoulder Range of Motion</title>
          <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Affected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.5" spread="5.0"/>
                    <measurement group_id="O2" value="157.1" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unaffected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.5" spread="6.9"/>
                    <measurement group_id="O2" value="163.7" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Affected Arm Only</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.264</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unaffected arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.224</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Degrees of Shoulder Range of Motion</title>
        <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Degrees of Shoulder Range of Motion</title>
          <description>Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.</description>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Affected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.5" spread="6.0"/>
                    <measurement group_id="O2" value="165.5" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unaffected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.3" spread="7.5"/>
                    <measurement group_id="O2" value="164.6" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Affected arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.125</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unaffected arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.241</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Grip Score</title>
        <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilogram of force) calculated. A higher score indicates a greater grip strength.</description>
        <time_frame>At Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Grip Score</title>
          <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilogram of force) calculated. A higher score indicates a greater grip strength.</description>
          <units>kilograms of force</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Affected Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="4.7"/>
                    <measurement group_id="O2" value="21.5" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unaffected Arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="6.8"/>
                    <measurement group_id="O2" value="24.5" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Affected Arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.261</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unaffected Arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.597</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Grip Score</title>
        <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilograms of force) calculated. A higher score indicates a greater grip strength.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Grip Score</title>
          <description>Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilograms of force) calculated. A higher score indicates a greater grip strength.</description>
          <units>kilograms of force</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Affected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="6.6"/>
                    <measurement group_id="O2" value="25.2" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unaffected arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" spread="6.1"/>
                    <measurement group_id="O2" value="22.6" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Affected arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.596</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Unaffected arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.219</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Karnofsky Performance Status (KPS) Score</title>
        <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Karnofsky Performance Status (KPS) Score</title>
          <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.12" spread="13.79"/>
                    <measurement group_id="O2" value="88.18" spread="8.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.842</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Karnofsky Performance Status (KPS) Score</title>
        <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Karnofsky Performance Status (KPS) Score</title>
          <description>Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8" spread="4.04"/>
                    <measurement group_id="O2" value="90.91" spread="9.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</title>
        <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</title>
          <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="2.09"/>
                    <measurement group_id="O2" value="3.42" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.300</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</title>
        <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
        <time_frame>4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores</title>
          <description>The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a &quot;yes/no&quot; format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="2.09"/>
                    <measurement group_id="O2" value="3.42" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.300</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Norman Questionnaire (NQ) Scores</title>
        <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Norman Questionnaire (NQ) Scores</title>
          <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.83" spread="2.76"/>
                    <measurement group_id="O2" value="4.27" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.679</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Norman Questionnaire (NQ) Scores</title>
        <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Norman Questionnaire (NQ) Scores</title>
          <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="1.87"/>
                    <measurement group_id="O2" value="4.27" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.120</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Norman Questionnaire (NQ) Scores</title>
        <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
        <time_frame>At 4 months</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 months</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Norman Questionnaire (NQ) Scores</title>
          <description>The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms</description>
          <population>Only a subset of participants completed the questionnaire at 4 months</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" spread="1.89"/>
                    <measurement group_id="O2" value="4.56" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.138</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</title>
        <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</title>
          <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.40" spread="16.83"/>
                    <measurement group_id="O2" value="21.45" spread="18.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.096</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</title>
        <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores</title>
          <description>The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.20" spread="16.03"/>
                    <measurement group_id="O2" value="17.62" spread="18.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</title>
        <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</title>
          <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.86" spread="6.26"/>
                    <measurement group_id="O2" value="44.70" spread="7.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</title>
        <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)</title>
          <description>The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 &quot;not at all&quot; to 5 &quot;very much.&quot; Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.35" spread="6.40"/>
                    <measurement group_id="O2" value="43.14" spread="8.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.080</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</title>
        <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</title>
          <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" spread="1.0"/>
                    <measurement group_id="O2" value="17.6" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="3.0"/>
                    <measurement group_id="O2" value="6.8" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.3"/>
                    <measurement group_id="O2" value="6.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="2.7"/>
                    <measurement group_id="O2" value="9.6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Disturbance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.3"/>
                    <measurement group_id="O2" value="10.0" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Roles/Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="2.3"/>
                    <measurement group_id="O2" value="15.1" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.5"/>
                    <measurement group_id="O2" value="7.5" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Function Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.068</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anxiety Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.808</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Depression Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.557</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fatigue Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.049</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sleep Disturbance Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.279</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Roles/Activity Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.020</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain Interference Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</title>
        <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)</title>
          <description>The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.</description>
          <population>Only a subset of participants completed the questionnaire at 4 weeks</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="0.40"/>
                    <measurement group_id="O2" value="17.2" spread="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="1.3"/>
                    <measurement group_id="O2" value="6.7" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.0"/>
                    <measurement group_id="O2" value="5.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="2.8"/>
                    <measurement group_id="O2" value="8.9" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Disturbance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="3.1"/>
                    <measurement group_id="O2" value="10.4" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Roles/Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.5" spread="2.4"/>
                    <measurement group_id="O2" value="13.9" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interference</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="1.4"/>
                    <measurement group_id="O2" value="7.9" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Function Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anxiety Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.108</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Depression Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.467</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Fatigue Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.078</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sleep Disturbance Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.147</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Roles/Activity Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain Interference Domain</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.032</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</title>
        <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
        <time_frame>At Baseline</time_frame>
        <population>Only a subset of participants completed the questionnaire at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</title>
          <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
          <population>Only a subset of participants completed the questionnaire at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.3" spread="21.8"/>
                    <measurement group_id="O2" value="113.6" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.938</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</title>
        <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at week 4</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores</title>
          <description>The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.</description>
          <population>Only a subset of participants completed the questionnaire at week 4</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.4" spread="14.4"/>
                    <measurement group_id="O2" value="114.7" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.603</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Body Image Scale (BIS) Score</title>
        <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
        <time_frame>At baseline</time_frame>
        <population>Only a subset of participants completed the assessment at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Body Image Scale (BIS) Score</title>
          <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
          <population>Only a subset of participants completed the assessment at baseline</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="6.6"/>
                    <measurement group_id="O2" value="9.4" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.837</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Body Image Scale (BIS) Score</title>
        <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
        <time_frame>At 4 weeks</time_frame>
        <population>Only a subset of participants completed the questionnaire at week 4</population>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Body Image Scale (BIS) Score</title>
          <description>The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 &quot;not at all&quot; to 3 &quot;very much&quot;). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance</description>
          <population>Only a subset of participants completed the questionnaire at week 4</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="6.4"/>
                    <measurement group_id="O2" value="9.5" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.511</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores</title>
        <description>Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (FACIT-TSG- Version 4). The FACIT-TSG is a copyrighted 8-item questionnaire, with each item score ranging from 0 (&quot;not at all&quot;) to 4 (&quot;very much&quot;). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.</description>
        <time_frame>At 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Manual Lymph Drainage</title>
            <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
          </group>
          <group group_id="O2">
            <title>Negative Pressure</title>
            <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores</title>
          <description>Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (FACIT-TSG- Version 4). The FACIT-TSG is a copyrighted 8-item questionnaire, with each item score ranging from 0 (&quot;not at all&quot;) to 4 (&quot;very much&quot;). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="5.9"/>
                    <measurement group_id="O2" value="27.0" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.326</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 4 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Manual Lymph Drainage</title>
          <description>Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.</description>
        </group>
        <group group_id="E2">
          <title>Negative Pressure</title>
          <description>PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb&#xD;
PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Limb Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Shoulder/Neck Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Elbow Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Leukemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Betty Smoot, DPTSc, PT</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>(707) 494-8262</phone>
      <email>Betty.Smoot@ucsf.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252145
org study id: P0518095
secondary id: NCI-2018-00009
secondary id: 16802
nct id: NCT03252145
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a
      negative pressure massage device (intervention group), to the standard manual lymph drainage
      massage (control group), in breast cancer patients with chronic upper extremity lymphedema.
Lymphedema (LE) is a protein-rich interstitial swelling caused by reduced lymph transport
      secondary to lymphatic system damage from cancer treatments. 1 in 5 women will develop LE
      following breast cancer treatment. These women have greater restrictions in activity and
      poorer quality of life (QOL) and are more prone to cellulitis than women without LE. LE is
      incurable and progressive. Persistent lymph stasis creates a condition of chronic
      inflammation that contributes to fibrosis and fatty deposition in the subcutis of the
      affected limb. The fibro-adipose changes associated with chronic LE make it less responsive
      to treatments that primarily target limb volume. Treatments are needed that can improve these
      skin and subcutaneous tissues changes, as well as reduce limb volume.

      This 4 to 6 week randomized controlled pilot feasibility study will enroll 80 women with
      chronic arm LE, and will evaluate a novel negative pressure massage device that mobilizes
      skin and subcutaneous tissue. This negative pressure treatment provides vertical (lifting)
      and horizontal stretching of the skin and underlying fascial structures, which increases the
      subcutaneous space for lymphatic circulation, improves lymph flow, and has the potential to
      decrease fibrosis. This treatment will be compared to the standard of care massage: manual
      lymphatic drainage. Women will be randomly assigned to either the negative pressure massage
      device (intervention group), to the standard manual lymph drainage massage (control group)

      Objectives: To evaluate recruitment and retention rates; to determine rates of adverse
      events; and to determine effect sizes for limb volume, tissue induration; and patient
      reported outcomes of arm function, QOL, and body image in response to treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recruitment Rates
time frame: At 4 weeks
description: The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.
measure: Percentage of Participants Who Completed All Study Visits
time frame: At 4 weeks
description: Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.
measure: Mean Limb Volume
time frame: At Baseline
description: Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)
measure: Mean Limb Volume
time frame: At 4 weeks
description: Arm circumferential measurements of both limbs and hands were taken twice, using a spring-loaded tape measure. The hand was measured in two locations. Upper extremity measurements were taken at 10 centimeter (cm) intervals from the ulnar styloid of the wrist up to a total distance of 40 cm. Circumferences were measured using the procedures outlined by Cornish et al. Limb volume was calculated using the formula for volume of a truncated cone and reported in millilitre (ml)
measure: Mean Lymphedema Index (L-DEX®) Ratio Scores
time frame: At Baseline
description: Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms & 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.
measure: Mean L-DEX® Scores
time frame: At 4 weeks
description: Bioimpedance spectroscopy (BIS) measurements were taken using a single channel BIS, tetrapolar device (LDex device, ImpediMed, San Diego, CA) to evaluate upper limb bioelectrical impedance. Impedance ratios (unaffected/affected limb) are calculated and converted to L-Dex ratio score. With development of lymphedema, impedance of extremity decreases and L-Dex ratio therefore increases. An L-Dex ratio score of 10 is equivalent to impedance ratio of 1.139 (which is = to 3 standard deviations (SD) from mean normative BIS data) for at-risk dominant arms & 1.066 for at-risk non-dominant arms, respectively. Each 1 standard unit in L-Dex is equivalent to impedance ratio of 0.03. Using this arbitrary scale relevant to normative standards, a patient is determined to have arm lymphedema if L-Dex ratio score exceeds 7.1, which is 2 SD above mean normative data for BIS impedance ratios. Higher L-Dex ratio score means higher impedance ratio between limbs, which means more volume in affected limb.
measure: Mean Skin Induration Score
time frame: At Baseline
description: The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.
measure: Mean Skin Induration Score
time frame: At 4 weeks
description: The SkinFibroMeter (Delfin Technologies, Finland) was used to measure tissue induration. The SkinFibroMeter consists of a 1 mm long indenter and a force sensor. The device is gently pressed against the skin. The indenter imposes a constant deformation when the reference plate is in full contact with the skin. The skin and the underlying superficial subcutis resist the deformation. Measurements will be taken bilaterally at 5 locations: the first dorsal web space; the medial forearm halfway between the ulnar styloid and medial epicondyle; the lateral forearm halfway between the radial styloid and the lateral epicondyle; the medial arm 3 inches proximal to the medial epicondyle; and the lateral arm 3 inches proximal to the lateral epicondyle. Five recordings were taken at each location and a mean score was calculated.The induration value in Newtons (N) is recorded.
measure: Mean Degrees of Shoulder Range of Motion
time frame: At Baseline
description: Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.
measure: Mean Degrees of Shoulder Range of Motion
time frame: At 4 weeks
description: Active shoulder flexion and abduction range of motion (ROM) was assessed, with patients supine, using a goniometer and standardized procedures reported by Norkin and White. Bilateral ROM was assessed. Two measurements will be taken for each motion and a mean obtained, for each, bilaterally. Findings are recorded in degrees.
measure: Mean Grip Score
time frame: At Baseline
description: Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilogram of force) calculated. A higher score indicates a greater grip strength.
measure: Mean Grip Score
time frame: At 4 weeks
description: Grip strength was assessed using a Jamar hydraulic hand dynamometer (Patterson Medical, Bolingbrook, IL). Patients will be tested in sitting with the feet flat on the floor, the arm at the side with the elbow flexed to 90 degrees. The patient was instructed to maximally squeeze the handle and hold for a count of 3. The peak-hold needle will automatically record the highest force exerted. Two trials for each extremity will be done and a mean grip score (in kilograms of force) calculated. A higher score indicates a greater grip strength.
measure: Mean Karnofsky Performance Status (KPS) Score
time frame: At Baseline
description: Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.
measure: Mean Karnofsky Performance Status (KPS) Score
time frame: At 4 weeks
description: Participants rated their functional status using the single item KPS scale with a range from 0 (dead) to 100 (I feel normal; I have no complaints or symptoms), in increments of 10 (0,10,20, 30 , 40...). The lower the Karnofsky score, the worse the impairment.
measure: Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
time frame: At Baseline
description: The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a "yes/no" format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.
measure: Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores
time frame: 4 weeks
description: The SCQ consists of 13 common medical conditions that are simplified into language that could be understood without any prior medical knowledge. Patients were asked to indicate if they had the condition using a "yes/no" format. If they indicate that they had a condition, they are asked if they received treatment for it (yes/no; proxy for disease severity) and did it limit their activities (yes/no; indication of functional limitations). • For each condition, a patient can receive a maximum of 3 points. Because there are 13 defined medical conditions and 2 optional conditions, the maximum achievable total score is 45 points as all items were available for use.
measure: Mean Norman Questionnaire (NQ) Scores
time frame: At Baseline
description: The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms
measure: Mean Norman Questionnaire (NQ) Scores
time frame: At 4 weeks
description: The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms
measure: Mean Norman Questionnaire (NQ) Scores
time frame: At 4 months
description: The NQ was originally developed and validated as a phone interview questionnaire to describe the signs and symptoms of breast cancer-related lymphoedema. Participants report subjective differences in the size of the hands, lower arms, and/or upper arms between their right and left sides. For each site difference, the reported score can range from 1 (very slight difference) to 3 (very noticeable difference). The total score can range from 1 (very slight difference at 1 site) to 9 (very noticeable difference at all 3 sites). Higher scores indicate a greater noticeable difference between the two arms
measure: Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
time frame: At Baseline
description: The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.
measure: Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores
time frame: At 4 weeks
description: The DASH is a 30-item self-report questionnaire measuring upper limb symptoms and ability to perform common functional activities in people with musculoskeletal disorders of the upper limb. The disability/symptom questions are scored 1 thru 5, with 1=being no difficulty and 5=being unable to perform. At least 27 of the 30 items must be completed for a scaled score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a raw score between 1 and 5. This value is then transformed to a score out of 100 to create a DASH disability/symptom score = [(sum of (n) responses) - 1] x 25, where n is equal to the number of completed responses. Each scaled score cut point is scored as 0 (no disability), 25 (mild disability), 50 (moderate), 75 (severe) and 100 (unable to perform activities). Higher scores indicate greater limitation.
measure: Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
time frame: At Baseline
description: The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 "not at all" to 5 "very much." Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.
measure: Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)
time frame: At 4 weeks
description: The PROMIS for the Upper Extremity is reliable and addresses disability with physical activities that involve upper limb activities. The instrument items include 5 response options, from 1 "not at all" to 5 "very much." Total scores range from 0 to 100. PROMIS UE scores are scored using a T-score metric, with higher scores indicate higher levels of physical functioning of the upper extremity.
measure: Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
time frame: At Baseline
description: The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.
measure: Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)
time frame: At 4 weeks
description: The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning.
measure: Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
time frame: At Baseline
description: The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.
measure: Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores
time frame: At 4 weeks
description: The FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.
measure: Mean Body Image Scale (BIS) Score
time frame: At baseline
description: The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance
measure: Mean Body Image Scale (BIS) Score
time frame: At 4 weeks
description: The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance
measure: Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores
time frame: At 4 weeks
description: Satisfaction with treatment will be evaluated at the 4-week assessment using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (FACIT-TSG- Version 4). The FACIT-TSG is a copyrighted 8-item questionnaire, with each item score ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.
arm group label: Negative Pressure
arm group type: Experimental
description: PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
arm group label: Manual Lymph Drainage
arm group type: Active Comparator
description: Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb
intervention type: Device
intervention name: PhysioTouch
description: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.
arm group label: Negative Pressure
intervention type: Other
intervention name: Manual Lymph Drainage (MLD)
description: MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.
arm group label: Manual Lymph Drainage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Betty Smoot, DPTSc, MAS
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 