Massage for Muscle Pain

Overseen By Kayla Russell-Bertucci

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Fibromyalgia, Metastatic cancer, 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a 30-minute myofascial massage (also known as myofascial release or medical massage) affects shoulder muscle stiffness and blood flow. Researchers are also examining how varying levels of communication between the therapist and participant might influence these effects. The trial is suitable for individuals who completed breast cancer treatment 3 months to 2 years ago and are experiencing upper chest muscle pain. As an unphased trial, it offers a unique opportunity to contribute to understanding the benefits of massage therapy for post-cancer treatment pain relief.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that you should not be undergoing other treatments for side effects related to your cancer diagnosis.

What prior data suggests that myofascial massage is safe for muscle pain?

Research has shown that myofascial massage is generally safe for most people. It can relieve muscle pain by loosening tight muscles and joints. However, like any treatment, incorrect application carries some risks. Serious problems rarely occur when a trained therapist performs the massage.

In studies of massage therapy, only a few participants experienced minor soreness or discomfort afterward. Most individuals tolerate the massage well. Ensuring the therapist is qualified and uses the correct technique reduces any risks. Overall, myofascial massage is considered a safe way to ease muscle pain when performed by a professional. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using myofascial massage for muscle pain because it offers a fresh approach by incorporating distinct levels of communication between the therapist and participant. Unlike standard muscle pain treatments, which often involve medications like NSAIDs or physical therapy exercises, this trial explores how different communication styles during massage might enhance pain relief and improve outcomes. This unique focus on therapist-participant interaction could uncover new insights into the role of communication in pain management, potentially leading to more personalized and effective care strategies.

What evidence suggests that myofascial massage is effective for muscle pain?

Research has shown that myofascial massage, which participants in this trial will receive, can help reduce muscle pain. Studies have found it more effective for myofascial pain than doing nothing or using a placebo. One study discovered that combining myofascial release with specific exercises greatly reduced pain and improved movement in nurses. This treatment loosens tight muscles and increases blood flow, easing pain and improving movement. While results can vary, evidence supports its potential benefits for muscle-related discomfort. Participants in this trial will experience different levels of communication during the massage, explained at the study's conclusion. ^{3 6 7 8 9}

Who Is on the Research Team?

David Lipps, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who finished primary treatment 3 months to 2 years ago and are experiencing myofascial pain in the upper chest. Participants must understand and agree to the study's terms. Those with fibromyalgia, unrelated chronic injuries affecting arm function, ongoing treatments for other cancers or physical therapies, or broken skin in the area cannot join.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent.

I was diagnosed with breast cancer in one breast.

I finished my primary breast cancer treatment between 3 months and 2 years ago, except for oral maintenance.

Exclusion Criteria

I have been diagnosed with fibromyalgia.

I have a long-term muscle or bone injury in my arm that is not because of my cancer.

Currently receiving treatment for other forms of cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 30-minute myofascial massage with varying levels of patient-therapist communication

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in muscle stiffness and perfusion after treatment

1 hour

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Myofascial Massage

Trial Overview The study aims to see if a 30-minute myofascial massage can make shoulder muscles less stiff and improve blood flow within them. It also looks at whether talking more with therapists during the session makes these effects stronger.

How Is the Trial Designed?

Group I: Massage with communication level 2 Experimental Treatment 1 Intervention

The therapist and the participant will have this level of communication (known as level 2). Further details will be explained at the end of the study.

Group II: Massage with communication level 1 Experimental Treatment 1 Intervention

The therapist and the participant will have this level of communication (known as level 1 here). Further details will be explained at the end of the study.

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?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Myofascial release (MFR) significantly enhances wound healing in bioengineered tendons, with optimal results observed at lower strain magnitudes (3% strain) and longer durations (up to 5 minutes), leading to a notable reduction in wound size.

The study found that the effects of MFR on wound healing are likely due to modifications in the extracellular matrix protein architecture, with significant changes in wound area detectable as early as 3 hours after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration and magnitude of myofascial release in 3-dimensional bioengineered tendons: effects on wound healing. Cao, TV., Hicks, MR., Zein-Hammoud, M., et al.[2022]

Myofascial release (MFR) combined with specific back exercises significantly reduced pain by 53.3% and functional disability by 29.7% in nursing professionals with chronic low back pain after 8 weeks, compared to a control group that only saw reductions of 26.1% and 9.8%, respectively.

The study, involving 80 participants over 8 weeks, showed that 73% of those receiving MFR experienced at least a 50% reduction in pain, highlighting its effectiveness as an adjunct therapy for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of myofascial release in the management of chronic low back pain in nursing professionals. Ajimsha, MS., Daniel, B., Chithra, S.[2014]

In a study involving 63 patients with acute low back pain, those receiving compression at myofascial trigger points (MTrPs) showed significant improvements in pain intensity and range of motion compared to those receiving compression at non-trigger points or superficial massage.

The results suggest that targeting MTrPs with compression is an effective treatment for acute low back pain, highlighting its potential as a therapeutic intervention in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of compression at myofascial trigger points in patients with acute low back pain: A randomized controlled trial. Takamoto, K., Bito, I., Urakawa, S., et al.[2022]

A systematic review of randomized controlled trials on myofascial release (MFR) therapy indicates that while the quality of studies varies, recent research shows promising results for its effectiveness in treating various conditions and pain.

MFR is gaining recognition as a viable treatment option, supported by an emerging evidence base, which suggests it has the potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of myofascial release: systematic review of randomized controlled trials. Ajimsha, MS., Al-Mudahka, NR., Al-Madzhar, JA.[2022]

Myofascial release therapy resulted in significantly lower pain intensity scores compared to both the control group and the passive muscle stretching group after eight weeks, indicating its potential effectiveness for managing fibromyalgia pain.

Participants in the myofascial release group also reported better health status, as measured by the fibromyalgia impact questionnaire, compared to the control group after four and eight weeks, although no significant differences were found between the myofascial release and stretching groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of myofascial release of the physiological chains on the pain and health status in patients with fibromyalgia, compared to passive muscle stretching and a control group: a randomized controlled clinical trial. Schulze, NBB., Barreto, TDNP., Alencar, GG., et al.[2023]

Myofascial release (MFR) significantly improved pressure pain thresholds in the trapezius and suboccipital muscles of individuals with chronic mechanical neck pain, based on a systematic review of 13 studies involving 601 participants.

Despite these improvements in pain thresholds, MFR did not show significant effects on overall pain levels, cervical mobility, or neck disability index, indicating that while MFR may help with specific muscle sensitivity, its broader efficacy for neck pain relief is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofascial release for the treatment of pain and dysfunction in patients with chronic mechanical neck pain: Systematic review and meta-analysis of randomised controlled trials. Guo, Y., Lv, X., Zhou, Y., et al.[2023]

A systematic review of 8 randomized controlled trials involving 512 participants found that myofascial release therapy did not significantly improve pain or disability in conditions like low back pain and fibromyalgia, as the effect sizes did not meet the minimal clinically important difference.

While some studies showed short-term benefits in pain relief, the overall evidence is insufficient to support myofascial release therapy as an effective treatment for chronic musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of myofascial release in treatment of chronic musculoskeletal pain: a systematic review. Laimi, K., Mäkilä, A., Bärlund, E., et al.[2022]

In a randomized, placebo-controlled trial involving 86 patients with fibromyalgia, myofascial release techniques significantly reduced pain symptoms and improved physical function after 20 weeks of treatment.

While myofascial release showed benefits in pain and clinical severity, it did not enhance postural stability, indicating its role as a complementary therapy rather than a comprehensive solution for all fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Castro-Sánchez, AM., Matarán-Peñarrocha, GA., Arroyo-Morales, M., et al.[2022]

Myofascial release significantly reduces pain in fibromyalgia patients, showing a large effect immediately after treatment and a moderate effect at 6 months post-treatment, based on a review of six studies with 279 participants.

The review provides moderate evidence that both therapist-administered and self-myofascial release can improve pain, sleep quality, and overall quality of life in fibromyalgia patients compared to sham treatments, but emphasizes the need for more high-quality randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of myofascial release on pain, sleep, and quality of life in patients with fibromyalgia syndrome: A systematic review. Ughreja, RA., Venkatesan, P., Balebail Gopalakrishna, D., et al.[2021]

A 54-year-old woman with rheumatoid arthritis and collagenous colitis experienced significant improvements in pain, fatigue, gastrointestinal function, and cervical range of motion after six sessions of sustained release myofascial release (MFR) therapy over two weeks.

The positive effects on her symptoms and quality of life were maintained for five weeks after treatment, indicating that MFR may offer both short-term and long-term benefits when used alongside standard medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained release myofascial release as treatment for a patient with complications of rheumatoid arthritis and collagenous colitis: a case report. Cubick, EE., Quezada, VY., Schumer, AD., et al.[2021]

Self-myofascial release (SMFR), particularly through foam rolling, has been shown to significantly increase joint range of motion without negatively affecting muscle force or performance, making it a safe option for recovery and maintenance.

Despite its widespread use by health-care professionals for treating myofascial pain, there is a lack of clinical trials specifically evaluating the effectiveness of SMFR in this context, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of self-myofascial release on myofascial pain, muscle flexibility, and strength: A narrative review. Kalichman, L., Ben David, C.[2022]

Myofascial release (MFR) significantly increased range of motion (ROM) and pain pressure thresholds (PPT) in both local and distal areas, indicating its effectiveness in enhancing tissue elasticity and overall systemic response.

The study suggests that baseline interoceptive sensitivity may help predict improvements in ROM and PPT following MFR, highlighting a potential link between bodily awareness and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate biomechanical, systemic, and interoceptive effects of myofascial release on the thoracic spine: A randomised controlled trial. Cathcart, E., McSweeney, T., Johnston, R., et al.[2019]

In a study of 59 participants with occupational mechanical neck pain, myofascial release therapy was found to be more effective than manual therapy in improving neck motion and quality of life after five treatment sessions.

Myofascial release therapy significantly improved the craniovertebral angle and cervical motion (side bending and rotation) compared to manual therapy, indicating its potential as a superior treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myofascial Release Therapy in the Treatment of Occupational Mechanical Neck Pain: A Randomized Parallel Group Study. Rodríguez-Fuentes, I., De Toro, FJ., Rodríguez-Fuentes, G., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25603749/

Effectiveness of myofascial release: systematic review ... Conclusions: The literature regarding the effectiveness of MFR was mixed in both quality and results. Although the quality of the RCT studies varied greatly, ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821154

Use of Massage Therapy for Pain, 2018-2023 Compared with no treatment, placebo, and active therapies, massage therapy has shown “a greater effect [on myofascial pain].” Kannan et al, 2022 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1521694224000159

Myofascial pain – A major player in musculoskeletal pain Myofascial pain is most effectively treated with a multimodal treatment plan including injection therapy (known as trigger point injections, physical therapy, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40163770/

Effectiveness of Massage Gun Versus Myofascial Release ... This study aimed to compare the effectiveness of a massage gun versus myofascial release technique on subjective pain, pain pressure threshold and ankle ROM ...

5. withpower.com withpower.com/trial/phase-facial-pain-11-2024-7f407

Massage for Muscle Pain · Info for Participants Myofascial release (MFR) combined with specific back exercises significantly reduced pain by 53.3% and functional disability by 29.7% in nursing professionals ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4145795/

Adverse Events of Massage Therapy in Pain-Related ... This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013.

7. mayoclinic.org mayoclinic.org/diseases-conditions/back-pain/expert-answers/myofascial-release/faq-20058136

Myofascial release therapy: Can it relieve back pain? The massage and stretching used in myofascial release therapy can help loosen muscles and joints. This may help indirectly ease your back pain.

8. somaflowinstitute.com somaflowinstitute.com/myofascial-release-dangers/

Myofascial Release Dangers [4 Risks Therapists Must Know] Myofascial release can be dangerous if applied without proper technique or anatomical awareness, especially for massage therapists working with clients who ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/00/NCT06679400/ICF_001.pdf

Effects of Myofascial Massage and Patient-therapist ... The purpose of the study is to quantify improvements to shoulder muscles following a single 30-minute session of massage (targeting the muscles around the ...