<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/NCT04484584</url>
  </required_header>
  <id_info>
    <org_study_id>Traumatic Edema</org_study_id>
    <nct_id>NCT04484584</nct_id>
  </id_info>
  <brief_title>Complex Decongestive Therapy on Distal Radius Fracture</brief_title>
  <official_title>The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also&#xD;
      reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to&#xD;
      exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged&#xD;
      exudation period create a physiological problem. It causes the recovery time of tissues to be&#xD;
      completed late and the functional gains to be delayed.&#xD;
&#xD;
      The aim of the study is to investigate the effect of Complex decongestive therapy on&#xD;
      traumatic edema, pain and functionality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are composed of patients who are referred to the physical medicine and&#xD;
      rehabilitation clinic. All patients eligible for the study were informed about treatment and&#xD;
      possible risks, and a consent form was signed. Determined evaluations were made to the&#xD;
      patients. After 3 weeks of treatment, patients will be invited to the controls and the&#xD;
      long-term effects of the treatments will be investigated.&#xD;
&#xD;
      Patients with a diameter difference of more than 50 ml between two extremities and patients&#xD;
      without Sudeck Atrophy will be included in the treatment.&#xD;
&#xD;
      The study was planned as a single blind with randomized control. The physiotherapist who&#xD;
      performed the treatment received manual lymph drainage therapy training.&#xD;
&#xD;
      The patients were distributed to groups with a computer-based data distribution system. While&#xD;
      the patients are sent for treatment, they are directed according to the first assessment. The&#xD;
      person who performed the assessment and those who received treatment were planned&#xD;
      differently.&#xD;
&#xD;
      The primary purpose of the study was to investigate the long-term effectiveness of complex&#xD;
      decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions.&#xD;
      Other objectives are to investigate the long-term effects on range of motion, muscle&#xD;
      strength, grip strength, pain, and daily living activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 17, 2020</start_date>
  <completion_date type="Actual">July 17, 2021</completion_date>
  <primary_completion_date type="Actual">July 17, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Volumetric test measurement</measure>
    <time_frame>at baseline</time_frame>
    <description>Volumetric test measurement is more than 50 mL, edema is considered to be present.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volumetric test measurement</measure>
    <time_frame>4. week</time_frame>
    <description>Volumetric test measurement is more than 50 mL, edema is considered to be present.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Michigan Hand Outcomes Questionnarie</measure>
    <time_frame>at baseline</time_frame>
    <description>The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Michigan Hand Outcomes Questionnarie</measure>
    <time_frame>4. week</time_frame>
    <description>The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Rated Wrist Evaluation</measure>
    <time_frame>at baseline</time_frame>
    <description>The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:&#xD;
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Rated Wrist Evaluation</measure>
    <time_frame>4. week</time_frame>
    <description>The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:&#xD;
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick DASH</measure>
    <time_frame>at baseline</time_frame>
    <description>Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quick DASH</measure>
    <time_frame>4. week</time_frame>
    <description>Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myometer test</measure>
    <time_frame>at baseline</time_frame>
    <description>Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myometer test</measure>
    <time_frame>4.week</time_frame>
    <description>Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamometer test</measure>
    <time_frame>at baseline</time_frame>
    <description>A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 &lt; 34.7 34.7-54.5 &gt; 54.5 50-54 &lt; 32.9 32.9-50.7 &gt; 50.7 55-59 &lt; 30.7 30.7-48.5 &gt; 48.5 60-64 &lt; 30.2 30.2-48.0 &gt; 48.0 65-69 &lt; 28.2 28.2-44.0 &gt; 44.0 70-99 &lt; 21.3 21.3-35.1 &gt; 35.1 for females(in kg): 45-49 &lt; 18.6 18.6-32.4 &gt; 32.4 50-54 &lt; 18.1 18.1-31.9 &gt; 31.9 55-59 &lt; 17.7 17.7-31.5 &gt; 31.5 60-64 &lt; 17.2 17.2-31.0 &gt; 31.0 65-69 &lt; 15.4 15.4-27.2 &gt; 27.2 70-99 &lt; 14.7 14.7-24.5 &gt; 24.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamometer test</measure>
    <time_frame>4.week</time_frame>
    <description>A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 &lt; 34.7 34.7-54.5 &gt; 54.5 50-54 &lt; 32.9 32.9-50.7 &gt; 50.7 55-59 &lt; 30.7 30.7-48.5 &gt; 48.5 60-64 &lt; 30.2 30.2-48.0 &gt; 48.0 65-69 &lt; 28.2 28.2-44.0 &gt; 44.0 70-99 &lt; 21.3 21.3-35.1 &gt; 35.1 for females(in kg): 45-49 &lt; 18.6 18.6-32.4 &gt; 32.4 50-54 &lt; 18.1 18.1-31.9 &gt; 31.9 55-59 &lt; 17.7 17.7-31.5 &gt; 31.5 60-64 &lt; 17.2 17.2-31.0 &gt; 31.0 65-69 &lt; 15.4 15.4-27.2 &gt; 27.2 70-99 &lt; 14.7 14.7-24.5 &gt; 24.5</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Distal Radius Fracture</condition>
  <arm_group>
    <arm_group_label>Complex Decongestive Therapy Group (CDT)</arm_group_label>
    <description>Complex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol:&#xD;
Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles&#xD;
Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day.&#xD;
Patients can do exercises in bandages. The patient is given home education.&#xD;
The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthopedic Rehabilitation Group (OR)</arm_group_label>
    <description>Orthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home.&#xD;
Orthopedic Rehabilitation Treatment Protocol:&#xD;
Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise&#xD;
Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics)&#xD;
Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar.&#xD;
Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>complex decongestive therapy</intervention_name>
    <description>Manual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes.</description>
    <arm_group_label>Complex Decongestive Therapy Group (CDT)</arm_group_label>
    <arm_group_label>Orthopedic Rehabilitation Group (OR)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with distal radius fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 45 years&#xD;
&#xD;
          -  Unilateral distal radius fracture treated with plaster cast&#xD;
&#xD;
          -  Begin treatment after (7-10) days after removing the plaster&#xD;
&#xD;
          -  At least 50 mL of the volume difference between the upper extremities&#xD;
&#xD;
          -  Having signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated ulna fracture&#xD;
&#xD;
          -  Pathological fracture&#xD;
&#xD;
          -  polytrauma&#xD;
&#xD;
          -  Bilateral fractures&#xD;
&#xD;
          -  With chronic kidney disease&#xD;
&#xD;
          -  The presence of infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>meltem vural</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>banu aydeniz</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>tuba Altun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hasan Kerem Alptekin</last_name>
    <role>Study Director</role>
    <affiliation>Bahçeşehir University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr. Sadi konuk training and research hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34158</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Priganc V, Walter JR, Sublett SH. Edema assessment and management practice patterns among hand therapists: Survey research. J Hand Ther. 2020 Jul-Sep;33(3):378-385. doi: 10.1016/j.jht.2019.04.005. Epub 2019 Oct 14.</citation>
    <PMID>31623957</PMID>
  </reference>
  <reference>
    <citation>Rohner-Spengler M, Frotzler A, Honigmann P, Babst R. Effective Treatment of Posttraumatic and Postoperative Edema in Patients with Ankle and Hindfoot Fractures: A Randomized Controlled Trial Comparing Multilayer Compression Therapy and Intermittent Impulse Compression with the Standard Treatment with Ice. J Bone Joint Surg Am. 2014 Aug 6;96(15):1263-1271. doi: 10.2106/JBJS.K.00939.</citation>
    <PMID>25100773</PMID>
  </reference>
  <reference>
    <citation>Miller LK, Jerosch-Herold C, Shepstone L. Effectiveness of edema management techniques for subacute hand edema: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):432-446. doi: 10.1016/j.jht.2017.05.011. Epub 2017 Aug 12.</citation>
    <PMID>28807598</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Tuba Altun</investigator_full_name>
    <investigator_title>MSc,Physotherapist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04484584
org study id: Traumatic Edema
nct id: NCT04484584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also
      reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to
      exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged
      exudation period create a physiological problem. It causes the recovery time of tissues to be
      completed late and the functional gains to be delayed.

      The aim of the study is to investigate the effect of Complex decongestive therapy on
      traumatic edema, pain and functionality.
Patients are composed of patients who are referred to the physical medicine and
      rehabilitation clinic. All patients eligible for the study were informed about treatment and
      possible risks, and a consent form was signed. Determined evaluations were made to the
      patients. After 3 weeks of treatment, patients will be invited to the controls and the
      long-term effects of the treatments will be investigated.

      Patients with a diameter difference of more than 50 ml between two extremities and patients
      without Sudeck Atrophy will be included in the treatment.

      The study was planned as a single blind with randomized control. The physiotherapist who
      performed the treatment received manual lymph drainage therapy training.

      The patients were distributed to groups with a computer-based data distribution system. While
      the patients are sent for treatment, they are directed according to the first assessment. The
      person who performed the assessment and those who received treatment were planned
      differently.

      The primary purpose of the study was to investigate the long-term effectiveness of complex
      decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions.
      Other objectives are to investigate the long-term effects on range of motion, muscle
      strength, grip strength, pain, and daily living activities.
observational model: Cohort
time perspective: Prospective
measure: Volumetric test measurement
time frame: at baseline
description: Volumetric test measurement is more than 50 mL, edema is considered to be present.
measure: Volumetric test measurement
time frame: 4. week
description: Volumetric test measurement is more than 50 mL, edema is considered to be present.
measure: Michigan Hand Outcomes Questionnarie
time frame: at baseline
description: The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
measure: Michigan Hand Outcomes Questionnarie
time frame: 4. week
description: The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.
measure: Patient Rated Wrist Evaluation
time frame: at baseline
description: The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
measure: Patient Rated Wrist Evaluation
time frame: 4. week
description: The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales:
Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.
measure: Quick DASH
time frame: at baseline
description: Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
measure: Quick DASH
time frame: 4. week
description: Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: ([n total score / n] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.
measure: Myometer test
time frame: at baseline
description: Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
measure: Myometer test
time frame: 4.week
description: Myometer test is an electronic device used to measure muscle strength. It is directly proportional to the result of muscle strength. and the result will increase according to the force. 3 evaluations are made and the average is recorded. According to the manufacturer's specifications, the myometer used has a measurement range of 0 to 30kg with an overload rating to 40kg and an accuracy of ± 0.3kg, and is calibrated to within 0.1kg.
measure: Dynamometer test
time frame: at baseline
description: A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
measure: Dynamometer test
time frame: 4.week
description: A grip strength dynamometer is useful for testing your hand grip strength. for males (in kg): 45-49 < 34.7 34.7-54.5 > 54.5 50-54 < 32.9 32.9-50.7 > 50.7 55-59 < 30.7 30.7-48.5 > 48.5 60-64 < 30.2 30.2-48.0 > 48.0 65-69 < 28.2 28.2-44.0 > 44.0 70-99 < 21.3 21.3-35.1 > 35.1 for females(in kg): 45-49 < 18.6 18.6-32.4 > 32.4 50-54 < 18.1 18.1-31.9 > 31.9 55-59 < 17.7 17.7-31.5 > 31.5 60-64 < 17.2 17.2-31.0 > 31.0 65-69 < 15.4 15.4-27.2 > 27.2 70-99 < 14.7 14.7-24.5 > 24.5
arm group label: Complex Decongestive Therapy Group (CDT)
description: Complex Decongestive Therapy Group: The treatment was applied by a specialist therapist who received CDT training. The study group rehabilitation and CDT application is 1 hour. CDT Treatment Protocol:
Deep abdominal technique application Neck region CDT application (supraclavicular fossa circular motion-Eflöraj) Circular movements on ipsilateral Axillar lymph nodes Circular movements on bottle neck cubital fossa Front arm bucket pumping pump push MLD application of dorsal and palmar face of the hand to ulnar and radial bundles
Bandage Treatment (Fingers and hand and forearm bandage): Patients can stay for 6-8 hours or until the next day.
Patients can do exercises in bandages. The patient is given home education.
The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home. Orthopedic rehabilitation is the same as the control group.
arm group label: Orthopedic Rehabilitation Group (OR)
description: Orthopedic Rehabilitation Group: The treatment was made for approximately 30-45 minutes. Patients were given exercise training at home.
Orthopedic Rehabilitation Treatment Protocol:
Exercises to be done at 4 to 6 weeks: Wrist NEH (at the pain limit),active exercise,Grasp exercise
Exercises to be done at 6 to 8 weeks: Wrist NEH (at the pain limit),Active assistive / active exercise, Grasp exercise,Supination-pronation exercise. (Opposite baths and classical massage are recommended from orthopedics)
Exercises to be done at 8 to 10 weeks: Stretching exercises,Finger strengthening spring with Digiflex spring, Power web combo hand finger arm amplifier, Msd theraflex hand exercise dough, Theraband flevbar exercise bar.
Exercises to be done at 10 to 12 weeks Wrist strengthening exercises, Resistant exercises to all muscles.
intervention type: Other
intervention name: complex decongestive therapy
description: Manual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes.
arm group label: Complex Decongestive Therapy Group (CDT)
arm group label: Orthopedic Rehabilitation Group (OR)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: meltem vural
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
last name: banu aydeniz
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
last name: tuba Altun
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
last name: Hasan Kerem Alptekin
role: Study Director
affiliation: Bahçeşehir University
facility: 
country: Turkey
citation: Priganc V, Walter JR, Sublett SH. Edema assessment and management practice patterns among hand therapists: Survey research. J Hand Ther. 2020 Jul-Sep;33(3):378-385. doi: 10.1016/j.jht.2019.04.005. Epub 2019 Oct 14.
PMID: 31623957
citation: Rohner-Spengler M, Frotzler A, Honigmann P, Babst R. Effective Treatment of Posttraumatic and Postoperative Edema in Patients with Ankle and Hindfoot Fractures: A Randomized Controlled Trial Comparing Multilayer Compression Therapy and Intermittent Impulse Compression with the Standard Treatment with Ice. J Bone Joint Surg Am. 2014 Aug 6;96(15):1263-1271. doi: 10.2106/JBJS.K.00939.
PMID: 25100773
citation: Miller LK, Jerosch-Herold C, Shepstone L. Effectiveness of edema management techniques for subacute hand edema: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):432-446. doi: 10.1016/j.jht.2017.05.011. Epub 2017 Aug 12.
PMID: 28807598
responsible party type: Principal Investigator
investigator affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
investigator full name: Tuba Altun
investigator title: MSc,Physotherapist
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures