Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

Study Overview
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Brief Summary
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About 25-50% of women who undergo breast cancer surgery develop persistent chest wall pain and shoulder mobility limitations following surgery. The pain and mobility limitations adversely affect quality of life, sleep, and body image. Unfortunately, current treatments for pain and mobility limitations have variable efficacy. Based on a review of relevant pre-, intra-, and post-operative factors, investigators reasoned that myofascial massage may address contributors to pain and mobility limitations following breast cancer surgery. Investigators propose a randomized controlled trial looking at myofascial massage compared to a light touch group to look at the effects on pain and immobility following breast cancer surgery.

Detailed Description
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Myofascial massage is a deep tissue massage that focuses on muscles as well as the connective tissue that surrounds muscles, bones, and ligaments. The study team subsequently conducted a pilot randomized controlled trial involving 21 women with persistent pain and mobility limitations many months after surgery. They found that women who received myofascial massage to the affected breast/chest/shoulder had marked reductions in pain and mobility limitations and significant improvements in quality of life compared to a control group who received relaxation massage. They also established a practice-based research network of over 50 northeast Ohio massage therapists to guide future work. The study team now proposes a full scale randomized controlled trial involving 202 women with persistent pain and mobility limitations at 2 participating sites. To help differentiate between the specific effects of myofascial massage and non-specific effects due to prolonged touch and attention from a massage therapist, the study will include an active control group that will receive light touch. Participants in each group will receive 30 minutes of treatment twice weekly for 2 months. Primary analyses will determine the impact of myofascial massage on pain and mobility limitations. Secondary analyses will examine the impact of myofascial massage on a number of secondary outcomes, including range of motion, quality of life, sleep, and body image. Innovative features of the proposed project include a rigorous randomized controlled trial design, inclusion of an active control group, direct targeting of the affected breast/chest/shoulder, assessment of multiple mechanistic and patient-centered outcomes, and involvement of a massage practice-based research network. Investigators anticipate that the project will lead to a new and effective approach for addressing a major source of morbidity for women with breast cancer. Furthermore, the project may serve as a model for future trials of manual therapy among individuals with chronic medical conditions.

Official Title
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Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment

Conditions
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Breast Cancer, Mastectomy; Lymphedema, Pain, Shoulder, Mobility Limitation

Intervention / Treatment
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* Other: Myofascial Massage
* Other: Light Touch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Female Undergone breast cancer surgery 3-18 months ago Completed all treatment for breast cancer within the last 18 months (i.e. radiation, IV chemotherapy, surgery) Not expected to have any additional surgery (i.e. planning for reconstruction) Self reported chronic pain or immobility since surgery Exclusion Criteria: Under age 18 Not female Surgery < 3 months ago End all cancer treatments (surgery, radiation, chemotherapy) > 18 months ago Presence of lymphedema Open wounds or sores Currently on anticoagulants Currently receiving massage treatments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myofascial Massage<br>Participants randomized to this group will receive 30 minutes of myofascial massage to their affected breast, chest, and shoulder areas twice a week for 2 months. Therapists will follow a detailed 8 week protocol developed with a massage therapy consultant and the study team. | Other: Myofascial Massage<br>* The myofascial protocol outlines techniques, areas of the body, as well as time to be spent for each technique for a total of 25 minutes. The remaining 5 minutes of the massage are for the massage therapist to tailor myofascial massage to the needs and circumstances of each participant. In order to provide some level of customization, the therapist will determine the impact of massage on the participant's pre-existing pain and/or mobility limitations. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will use effleurage and petrissage techniques to gently massage the identified locations to soften and release the tissues. Techniques used will include deep friction of muscles, sustained compression, and fascial stretch.<br>|
| Active Comparator: Light Touch<br>Participants randomized to this group will receive 30 minutes of light touch to their affected breast, chest, and shoulder areas twice a week for 2 months. | Other: Light Touch<br>* Participants randomized to this group will receive 30 minutes of light touch to their affected breast, chest, and shoulder areas twice a week for 2 months. Therapists will follow a detailed light touch protocol for each of the 16 sessions. In addition, the therapist will inquire about the participant's response to the previous light touch treatment. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will place both hands on the participant for 3 minutes at each identified location. Pressure will be very light and consistent, with no side-to-side movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self reported pain scores | Shoulder Pain and Disability Index SPADI, 5 pain items rated on a 10 point likert scale, where 0 is no pain at all and 10 is the worst pain imaginable | Baseline, 1 month, 2 months, 8 months, and 14 months | 
| Change in self reported mobility scores | Shoulder Pain and Disability Index SPADI, 8 mobility items rated on a 10 point likert scale, where 0 means no issues with mobility and 10 means they are unable to complete the task | Baseline, 1 month, 2 months, 8 months, and 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Shoulder range of motion measured by goniometer and objective functional tasks | Baseline, 2 months, 14 months | 
| Pressure/Pain Threshold | Pressure to pain threshold as measured by algometer | Baseline, 2 months, 14 months | 
| Grip Strength | Hand grip strength measured by dynamometer | Baseline, 2 months, 14 months | 
| Tissue Flexibility | Change in tissue flexibility as measured by adherometer | Baseline, 2 months, 14 months | 
| Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B) | 44-item questionnaire designed to measure physical well-being, social/family well-being, emotional well-being, functional well-being, and additional breast cancer-specific concerns | Baseline, 2 months, 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast surgery, myofascial massage, shoulder immobility