Myofascial Massage for Post-Mastectomy Pain and Immobility

Overseen By Jacqueline Dolata, MBA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Lymphedema, Open wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

132 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for women over 18 who had breast cancer surgery between 3-18 months ago, are experiencing chronic pain or immobility since the operation, and have finished all treatments like radiation and chemotherapy within the last 18 months. It's not for those who ended treatment more than 18 months ago, have lymphedema, open wounds, are on anticoagulants or currently getting massages.

Inclusion Criteria

I have had chronic pain or trouble moving since my surgery.

I am not planning to have any more surgeries.

I had breast cancer surgery between 3 to 18 months ago.

Exclusion Criteria

I have open wounds or sores.

I had surgery less than 3 months ago.

I am not female.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 30 minutes of myofascial massage or light touch twice a week for 2 months

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person)

Treatment Details

Interventions

• Light Touch
• Myofascial Massage

Trial Overview The study compares myofascial massage to light touch therapy in women after breast cancer surgery to see which is better at reducing pain and improving shoulder mobility. Participants will be randomly assigned to one of these two approaches in a controlled setting.

Participant Groups

Group I: Myofascial Massage Experimental Treatment 1 Intervention

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 II: Light Touch Active Control 1 Intervention

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.

Myofascial Massage is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Myofascial Massage for:

• Relief of myofascial pain and stiffness in breast cancer survivors

Approved in European Union as Myofascial Release for:

• Management of post-surgical pain and restricted mobility in breast cancer patients

Approved in Canada as Myofascial Massage for:

• Improvement of shoulder muscle properties in breast cancer survivors with myofascial pain

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+