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Massage for Post Breast Surgery

Primary Purpose

Postmastectomy Lymphedema Syndrome, Pain, Shoulder Mobility Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Myofascial Massage Therapy
Global Relaxation Massage
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmastectomy Lymphedema Syndrome focused on measuring Post Breast Surgery, Myofascial Massage, Pain, Mobility Limitations

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age range 21-79 years of age
  • Female
  • Breast and/or axillary surgery
  • 2-18 months post-operative
  • Meets minimum pain and/or lack of mobility threshold as determined by survey
  • Ability to give informed consent
  • Ability to complete adherence task
  • Benign or malignant forms of disease

Exclusion Criteria:

  • History of blood clots
  • Mentally incompetent
  • Non-English speaking
  • Infected sites or open wounds
  • Currently lactating
  • Currently receiving massage therapy for breast surgery
  • Currently taking anticoagulants including:

Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux Heparin Tinzaparin Argatroban Bivalirudin Lepirudin

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental/Myofascial

Control/Global Relaxation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in self reported pain pre and post study
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.

Secondary Outcome Measures

Change in self reported mobility pre and post study
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.

Full Information

First Posted
September 24, 2014
Last Updated
May 14, 2018
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02250898
Brief Title
Massage for Post Breast Surgery
Official Title
Massage for Pain and Mobility in Post-Breast Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmastectomy Lymphedema Syndrome, Pain, Shoulder Mobility Impairment, Breast Surgery
Keywords
Post Breast Surgery, Myofascial Massage, Pain, Mobility Limitations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental/Myofascial
Arm Type
Experimental
Arm 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 Title
Control/Global Relaxation
Arm Type
Active Comparator
Arm 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(s)
Myofascial Massage Therapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Global Relaxation Massage
Intervention 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
Primary Outcome Measure Information:
Title
Change in self reported pain pre and post study
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in self reported mobility pre and post study
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.
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age range 21-79 years of age Female Breast and/or axillary surgery 2-18 months post-operative Meets minimum pain and/or lack of mobility threshold as determined by survey Ability to give informed consent Ability to complete adherence task Benign or malignant forms of disease Exclusion Criteria: History of blood clots Mentally incompetent Non-English speaking Infected sites or open wounds Currently lactating Currently receiving massage therapy for breast surgery Currently taking anticoagulants including: Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux Heparin Tinzaparin Argatroban Bivalirudin Lepirudin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwini Sehgal, MD
Organizational Affiliation
Ctr for Reducing Health Disparities
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44280
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15336336
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.
Results Reference
background
PubMed Identifier
22459520
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.
Results Reference
background
PubMed Identifier
22018755
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.
Results Reference
background
PubMed Identifier
19535099
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.
Results Reference
background
PubMed Identifier
12243507
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.
Results Reference
background
PubMed Identifier
21392372
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.
Results Reference
background
PubMed Identifier
8880841
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.
Results Reference
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Massage for Post Breast Surgery

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