Myofascial Massage for Pain and Immobility Following Breast Cancer Surgery

NCT ID: NCT04233385

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2025-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Myofascial Massage

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.

Group Type: EXPERIMENTAL

Myofascial Massage

Intervention Type: OTHER

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.

Light Touch

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.

Group Type: ACTIVE_COMPARATOR

Light Touch

Intervention Type: OTHER

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.

Interventions

Myofascial Massage

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.

Intervention Type: OTHER

Light Touch

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ash Sehgal

Co-Director Center for Reducing Health Disparities

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

IRB18-00912

Identifier Type: -

Identifier Source: org_study_id