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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if myofascial massage can reduce pain and improve mobility for women who have undergone breast cancer surgery. Many women experience ongoing pain and shoulder mobility issues post-surgery, affecting their daily lives. Participants will receive either myofascial massage, which targets muscle and connective tissue, or a light touch treatment to compare effects. Women who had breast cancer surgery 3 to 18 months ago and experience chronic pain or immobility may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to explore alternative pain relief methods and enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on anticoagulants (blood thinners).

What prior data suggests that myofascial massage is safe for post-mastectomy pain and immobility?

Research has shown that myofascial massage is generally safe and well-tolerated. Studies have found that this type of massage can reduce pain and improve movement in the chest, breast, and shoulder areas after breast cancer surgery. Reports of serious side effects are uncommon, and it is already used in Europe for similar purposes. Some individuals might experience mild discomfort during or after the massage, but this usually resolves quickly. Overall, myofascial massage appears to be a safe option for those experiencing pain and limited movement after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about myofascial massage for post-mastectomy pain and immobility because it offers a hands-on approach that directly targets the affected muscles and fascia, potentially providing relief from pain and improving mobility. Unlike standard treatments like medications or physical therapy, which primarily address symptoms or general physical rehabilitation, myofascial massage focuses on releasing tightness and enhancing flexibility in the specific areas impacted by surgery. This technique could offer a more personalized and immediate intervention for those struggling with discomfort and stiffness after a mastectomy. The potential for a non-invasive and drug-free alternative is what makes this approach particularly promising for improving quality of life after breast surgery.

What evidence suggests that myofascial massage might be an effective treatment for post-mastectomy pain and immobility?

Research shows that myofascial massage, which participants in this trial may receive, can help with pain and movement issues after breast cancer surgery. Studies have found that it significantly improves arm movement and reduces swelling. Myofascial massage also decreases long-term pain and enhances upper body use. These findings suggest it effectively addresses the pain and movement problems many women experience after surgery. Meanwhile, another group in this trial will receive light touch therapy, serving as an active comparator. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04233385

Myofascial Massage for Pain and Immobility Following ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190418/

Effects of Massage Therapy in Breast Cancer Survivors with ... The key findings demonstrated significant benefits, including improved range of motion, reduced arm circumference and lymphedema volume, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526820924002854

Nonpharmacological Interventions for Postmastectomy ... Myofascial massage for chronic pain and decreased upper extremity mobility after breast cancer surgery. Int J Ther Massage Bodywork, 11 (3) (2018) ...

4. withpower.com withpower.com/trial/phase-lymphedema-1-2020-3263b

Myofascial Massage for Post-Mastectomy Pain and ... 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 ...

5. mdpi.com mdpi.com/1660-4601/18/9/4420

Effect of Myofascial Therapy on Pain and Functionality ... The purpose was to analyze the effectiveness of myofascial therapy on musculoskeletal pain and functionality of the upper extremities in female breast cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728246/

Postmastectomy Functional Impairments - PubMed Central - NIH Postmastectomy functional impairments can be grouped into three categories: neuromuscular, musculoskeletal, and lymphovascular.