Massage for Post Breast Surgery

May 14, 2018 updated by: Ash Sehgal, MetroHealth Medical Center

Massage for Pain and Mobility in Post-Breast Surgery Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44280
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental/Myofascial
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.
Other: Myofascial Massage Therapy
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.
Active Comparator: Control/Global Relaxation
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.
Other: Global Relaxation Massage
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self reported pain pre and post study
Time Frame: 2 months
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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self reported mobility pre and post study
Time Frame: 2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Ashwini Sehgal, MD, Ctr for Reducing Health Disparities

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB13-01052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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