MR Elastography for Myofascial Pain Syndrome

Overseen By Timothy Waters

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Neurological conditions, Osteoarthritis, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to use a new imaging technique called Magnetic Resonance Elastography (MRE) to explore myofascial pain syndrome (MPS). Researchers will examine tissue behavior and properties to better understand the condition. Participants will include individuals with chronic low back or leg pain and noticeable muscle knots, as well as healthy volunteers without chronic pain in these areas. This study could improve future diagnosis and treatment of myofascial pain. As an unphased trial, participants can contribute to groundbreaking research that may enhance future diagnostic and treatment methods for myofascial pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for assessing myofascial pain syndrome?

Research has shown that Magnetic Resonance Elastography (MRE) is generally safe. The vibrations in MRE remain below the safety limits set by the European Union for the whole body, ensuring comfort for most individuals. Additionally, MRE is non-invasive, meaning it doesn't involve surgery or entering the body, which often reduces the risk of side effects. This study uses MRE to investigate myofascial pain syndrome, and previous research supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Magnetic Resonance Elastography (MRE) for myofascial pain syndrome because it offers a new way to visualize tissue stiffness, which is a key factor in this condition. Unlike traditional methods like physical therapy or pain medications that primarily focus on symptom management, MRE can potentially provide a detailed picture of the underlying tissue changes. By combining this with MRI structural imaging, researchers hope to better understand myofascial pain and improve diagnostic accuracy, paving the way for more targeted and effective treatments in the future.

What evidence suggests that MR Elastography is effective for assessing myofascial pain syndrome?

Research shows that Magnetic Resonance Elastography (MRE) is a promising tool for understanding myofascial pain syndrome (MPS). Studies have found that MRE measures tissue stiffness, aiding in the identification and assessment of tight muscle fibers that cause pain. This trial will use MRE to evaluate patients with myofascial-related pain diseases and healthy controls. This imaging technique could enhance the detection of muscle stiffness, a key factor in myofascial pain. By examining the physical properties of tissues, MRE might lead to improved diagnosis and management of MPS. ^{1 2 4 5 6}

Who Is on the Research Team?

Ziying Yin, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who have not had chronic pain in their lower back or legs that affects daily life. Participants should currently experience minimal pain (less than 0.5 on a 10-point scale) and must understand the study's purpose to give informed consent.

Inclusion Criteria

A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale)

I understand the study's purpose and agree to participate.

I have not had chronic pain in my lower back or legs that stopped me from daily activities or work.

Exclusion Criteria

I have had surgery on my back or legs.

I am unable to give consent for medical procedures.

I have had a severe back or leg injury in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo MRI imaging including MR elastography and MRI structural imaging

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Elastography
• MRI structural imaging

Trial Overview The study is testing Magnetic Resonance (MR) Elastography alongside MRI structural imaging to develop new ways of measuring myofascial tissue properties, which could help assess issues related to Myofascial Pain Syndrome.

How Is the Trial Designed?

Group I: Patients with myofascial-related pain diseases Experimental Treatment 2 Interventions

Subjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.

Group II: Healthy controls without myofascial-related pain diseases Experimental Treatment 2 Interventions

Subjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Magnetic resonance elastography (MRE) using high-density array coils allows for the acquisition of high-resolution images of tissue mechanical properties with significantly reduced scan times, demonstrating its efficacy in capturing shear wave propagation.

The study successfully demonstrated the ability to visualize changes in mechanical properties of agar samples in real-time, indicating that this advanced MRE technique could be beneficial for non-repeatable or destructive testing scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of highly accelerated magnetic resonance elastography using high-density array coils. Bosshard, JC., Yallapragada, N., McDougall, MP., et al.[2020]

In a study of 29 MRE exams across various tissues, the vibrational amplitudes used in magnetic resonance elastography (MRE) were found to be below the European Union's safety limits for whole-body vibrations, indicating a safe application for human studies.

The findings support the use of EU regulatory standards as a benchmark for vibrational exposure in MRE, which could help Institutional Review Boards establish safety guidelines for future human imaging trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration safety limits for magnetic resonance elastography. Ehman, EC., Rossman, PJ., Kruse, SA., et al.[2021]

Citations

1. mayo.edu mayo.edu/research/clinical-trials/cls-20544033

Magnetic Resonance Elastography of Myofascial Pain ... The purpose of this study is to develop MRE-based imaging biomarkers to measur the mechanical properties of the myofascial interface.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8166277/

Potential Role of MRI Imaging for Myofascial Pain MRE has the potential to improve detection of skeletal muscle stiffness, as it allows researchers to assess the biomechanical properties of ...

3. withpower.com withpower.com/trial/phase-pain-syndrome-myofascial-10-2022-54830

MR Elastography for Myofascial Pain Syndrome Magnetic Resonance Elastography (MRE) is a promising technique that can measure tissue stiffness, which is useful for identifying and assessing myofascial taut ...

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

Myofascial pain – A major player in musculoskeletal pain Myofascial pain is a soft tissue pain syndrome with local and referred musculoskeletal pain arising from trigger points.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mus.28377

Myofascial Pain Syndrome: An Update on Clinical ... One RCT in MPS patients found that oral flurbiprofen significantly improved pain severity, tenderness, ROM, and quality of life within the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11460881/

Current advances in the treatment of myofascial pain ... This method is low cost and less invasive, and early clinical applications have shown good efficacy. In this paper, we have reviewed clinical ...