<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/NCT02250898</url>
  </required_header>
  <id_info>
    <org_study_id>IRB13-01052</org_study_id>
    <nct_id>NCT02250898</nct_id>
  </id_info>
  <brief_title>Massage for Post Breast Surgery</brief_title>
  <official_title>Massage for Pain and Mobility in Post-Breast Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MetroHealth Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MetroHealth Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this study are to determine the effectiveness of myofascial massage specific to&#xD;
      the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among&#xD;
      patients who have undergone a mastectomy or other breast surgery compared to a control group&#xD;
      receiving global relaxation massages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative breast surgery patients may face an array of complications. Breast surgery can&#xD;
      include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012).&#xD;
      Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and&#xD;
      persistent issues in this population, however it is still unclear as to how many actually&#xD;
      suffer from these (Wallace 1996). Current treatment for each of these usually includes&#xD;
      prescribed narcotic pain medication and/or some physical therapy, the first being a treatment&#xD;
      with many side effects, the latter being quite expensive. Global and integrated massage&#xD;
      techniques have been used as a way of decreasing stress, anxiety, and some self-reported&#xD;
      pain, however a targeted massage technique geared towards the breast/chest/shoulder region&#xD;
      has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an&#xD;
      effective treatment for other post-surgical patients in reducing pain and increasing&#xD;
      mobility, but efficacy has yet to be shown specifically in post-breast surgery patients&#xD;
      (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive&#xD;
      and non-invasive addition to current pain and mobility treatment (Cassileth 2004).&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
      Aim A.&#xD;
&#xD;
      Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area&#xD;
      in reducing self-reported pain among patients who have undergone a mastectomy or other breast&#xD;
      surgery.&#xD;
&#xD;
      Aim B.&#xD;
&#xD;
      Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area&#xD;
      in increasing self-reported mobility in the affected shoulder among patients who have&#xD;
      undergone a mastectomy or other breast surgery.&#xD;
&#xD;
      Hypothesis: Compared to control patients receiving general full body massage, myofascial&#xD;
      massage specific to the breast/chest/shoulder area reduces pain and increases mobility in&#xD;
      patients who have undergone breast surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Change in self reported pain pre and post study</measure>
    <time_frame>2 months</time_frame>
    <description>Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self reported mobility pre and post study</measure>
    <time_frame>2 months</time_frame>
    <description>Self report survey of current mobility issues and restrictions in relation to the breast/chest/shoulder area will be given at the time of enrollment and after the 2 month study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Postmastectomy Lymphedema Syndrome</condition>
  <condition>Pain</condition>
  <condition>Shoulder Mobility Impairment</condition>
  <condition>Breast Surgery</condition>
  <arm_group>
    <arm_group_label>Experimental/Myofascial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control/Global Relaxation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myofascial Massage Therapy</intervention_name>
    <description>Myofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage.</description>
    <arm_group_label>Experimental/Myofascial</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Global Relaxation Massage</intervention_name>
    <description>Global Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being</description>
    <arm_group_label>Control/Global Relaxation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 21-79 years of age&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Breast and/or axillary surgery&#xD;
&#xD;
          -  2-18 months post-operative&#xD;
&#xD;
          -  Meets minimum pain and/or lack of mobility threshold as determined by survey&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Ability to complete adherence task&#xD;
&#xD;
          -  Benign or malignant forms of disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of blood clots&#xD;
&#xD;
          -  Mentally incompetent&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Infected sites or open wounds&#xD;
&#xD;
          -  Currently lactating&#xD;
&#xD;
          -  Currently receiving massage therapy for breast surgery&#xD;
&#xD;
          -  Currently taking anticoagulants including:&#xD;
&#xD;
        Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran&#xD;
        Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux&#xD;
        Heparin Tinzaparin Argatroban Bivalirudin Lepirudin&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashwini Sehgal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ctr for Reducing Health Disparities</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016.</citation>
    <PMID>15336336</PMID>
  </reference>
  <reference>
    <citation>Drackley NL, Degnim AC, Jakub JW, Cutshall SM, Thomley BS, Brodt JK, Vanderlei LK, Case JK, Bungum LD, Cha SS, Bauer BA, Boughey JC. Effect of massage therapy for postsurgical mastectomy recipients. Clin J Oncol Nurs. 2012 Apr;16(2):121-4. doi: 10.1188/12.CJON.121-124.</citation>
    <PMID>22459520</PMID>
  </reference>
  <reference>
    <citation>Fernandez-Lao C, Cantarero-Villanueva I, Diaz-Rodriguez L, Fernandez-de-las-Penas C, Sanchez-Salado C, Arroyo-Morales M. The influence of patient attitude toward massage on pressure pain sensitivity and immune system after application of myofascial release in breast cancer survivors: a randomized, controlled crossover study. J Manipulative Physiol Ther. 2012 Feb;35(2):94-100. doi: 10.1016/j.jmpt.2011.09.011. Epub 2011 Oct 21.</citation>
    <PMID>22018755</PMID>
  </reference>
  <reference>
    <citation>FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.</citation>
    <PMID>19535099</PMID>
  </reference>
  <reference>
    <citation>Khan SA, Apkarian AV. The characteristics of cyclical and non-cyclical mastalgia: a prospective study using a modified McGill Pain Questionnaire. Breast Cancer Res Treat. 2002 Sep;75(2):147-57. doi: 10.1023/a:1019685829799.</citation>
    <PMID>12243507</PMID>
  </reference>
  <reference>
    <citation>Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.</citation>
    <PMID>21392372</PMID>
  </reference>
  <reference>
    <citation>Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.</citation>
    <PMID>8880841</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 14, 2018</last_update_submitted>
  <last_update_submitted_qc>May 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MetroHealth Medical Center</investigator_affiliation>
    <investigator_full_name>Ash Sehgal</investigator_full_name>
    <investigator_title>Director, Center for Reducing Health Disparities</investigator_title>
  </responsible_party>
  <keyword>Post Breast Surgery</keyword>
  <keyword>Myofascial Massage</keyword>
  <keyword>Pain</keyword>
  <keyword>Mobility Limitations</keyword>
  <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>
  <!-- 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/NCT02250898
org study id: IRB13-01052
nct id: NCT02250898
lead sponsor: 
has dmc: No
The aims of this study are to determine the effectiveness of myofascial massage specific to
      the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among
      patients who have undergone a mastectomy or other breast surgery compared to a control group
      receiving global relaxation massages.
Post-operative breast surgery patients may face an array of complications. Breast surgery can
      include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012).
      Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and
      persistent issues in this population, however it is still unclear as to how many actually
      suffer from these (Wallace 1996). Current treatment for each of these usually includes
      prescribed narcotic pain medication and/or some physical therapy, the first being a treatment
      with many side effects, the latter being quite expensive. Global and integrated massage
      techniques have been used as a way of decreasing stress, anxiety, and some self-reported
      pain, however a targeted massage technique geared towards the breast/chest/shoulder region
      has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an
      effective treatment for other post-surgical patients in reducing pain and increasing
      mobility, but efficacy has yet to be shown specifically in post-breast surgery patients
      (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive
      and non-invasive addition to current pain and mobility treatment (Cassileth 2004).

      Specific Aims

      Aim A.

      Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area
      in reducing self-reported pain among patients who have undergone a mastectomy or other breast
      surgery.

      Aim B.

      Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area
      in increasing self-reported mobility in the affected shoulder among patients who have
      undergone a mastectomy or other breast surgery.

      Hypothesis: Compared to control patients receiving general full body massage, myofascial
      massage specific to the breast/chest/shoulder area reduces pain and increases mobility in
      patients who have undergone breast surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in self reported pain pre and post study
time frame: 2 months
description: Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.
measure: Change in self reported mobility pre and post study
time frame: 2 months
description: Self report survey of current mobility issues and restrictions in relation to the breast/chest/shoulder area will be given at the time of enrollment and after the 2 month study period.
arm group label: Experimental/Myofascial
arm group type: Experimental
description: The intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment.
arm group label: Control/Global Relaxation
arm group type: Active Comparator
description: The control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment.
intervention type: Other
intervention name: Myofascial Massage Therapy
description: Myofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage.
arm group label: Experimental/Myofascial
intervention type: Other
intervention name: Global Relaxation Massage
description: Global Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being
arm group label: Control/Global Relaxation
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ashwini Sehgal, MD
role: Principal Investigator
affiliation: Ctr for Reducing Health Disparities
facility: 
country: United States
citation: Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9. doi: 10.1016/j.jpainsymman.2003.12.016.
PMID: 15336336
citation: Drackley NL, Degnim AC, Jakub JW, Cutshall SM, Thomley BS, Brodt JK, Vanderlei LK, Case JK, Bungum LD, Cha SS, Bauer BA, Boughey JC. Effect of massage therapy for postsurgical mastectomy recipients. Clin J Oncol Nurs. 2012 Apr;16(2):121-4. doi: 10.1188/12.CJON.121-124.
PMID: 22459520
citation: Fernandez-Lao C, Cantarero-Villanueva I, Diaz-Rodriguez L, Fernandez-de-las-Penas C, Sanchez-Salado C, Arroyo-Morales M. The influence of patient attitude toward massage on pressure pain sensitivity and immune system after application of myofascial release in breast cancer survivors: a randomized, controlled crossover study. J Manipulative Physiol Ther. 2012 Feb;35(2):94-100. doi: 10.1016/j.jmpt.2011.09.011. Epub 2011 Oct 21.
PMID: 22018755
citation: FitzGerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2009 Aug;182(2):570-80. doi: 10.1016/j.juro.2009.04.022. Epub 2009 Jun 17.
PMID: 19535099
citation: Khan SA, Apkarian AV. The characteristics of cyclical and non-cyclical mastalgia: a prospective study using a modified McGill Pain Questionnaire. Breast Cancer Res Treat. 2002 Sep;75(2):147-57. doi: 10.1023/a:1019685829799.
PMID: 12243507
citation: Martin ML, Hernandez MA, Avendano C, Rodriguez F, Martinez H. Manual lymphatic drainage therapy in patients with breast cancer related lymphoedema. BMC Cancer. 2011 Mar 9;11:94. doi: 10.1186/1471-2407-11-94.
PMID: 21392372
citation: Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
PMID: 8880841
responsible party type: Principal Investigator
investigator affiliation: MetroHealth Medical Center
investigator full name: Ash Sehgal
investigator title: Director, Center for Reducing Health Disparities
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema