Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

MetroHealth Medical Center

Status: Completed

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

Treatments: Other: Light Touch; Other: Myofascial Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT04233385

IRB18-00912

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Myofascial Massage

Experimental group

Description:

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.

Treatment:

Other: Myofascial Massage

Light Touch

Active Comparator group

Description:

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.

Treatment:

Other: Light Touch