Clinical trial NCT04233385: Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery
Official title: Pain and Immobility After Breast Cancer Surgery: A Community-Based Randomized Controlled Trial of Myofascial Massage Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mastectomy; Lymphedema
Pain, Shoulder
Mobility Limitation
Keywords: breast cancer
breast surgery
myofascial massage
shoulder immobility
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self reported pain scores
timeFrame: Baseline, 1 month, 2 months, 8 months, and 14 months
measure: Change in self reported mobility scores
timeFrame: Baseline, 1 month, 2 months, 8 months, and 14 months
Secondary outcomes:
measure: Range of Motion
timeFrame: Baseline, 2 months, 14 months
measure: Pressure/Pain Threshold
timeFrame: Baseline, 2 months, 14 months
measure: Grip Strength
timeFrame: Baseline, 2 months, 14 months
measure: Tissue Flexibility
timeFrame: Baseline, 2 months, 14 months
measure: Quality of Life Survey-Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: Baseline, 2 months, 14 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
References:
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