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

106 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Magnetic Resonance Elastography (MRE) 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 bands, a key feature of Myofascial Pain Syndrome. MRE has been successfully used in other conditions to map tissue elasticity, such as in liver disease, and shows potential for detecting muscle stiffness, which may help in diagnosing and managing myofascial pain. ^{1 2 3 4 5}

Is magnetic resonance elastography (MRE) safe for humans?

Research indicates that the vibration levels used in magnetic resonance elastography (MRE) are below the safety limits set by the European Union for whole-body vibrations, suggesting that MRE is generally safe for human use. ^{3 4 6 7 8}

How does MR Elastography differ from other treatments for myofascial pain syndrome?

MR Elastography is unique because it uses a special MRI technique to create images that show the stiffness of tissues, helping to identify and measure myofascial taut bands, which are often associated with pain. Unlike traditional methods that rely on physical examination, this noninvasive imaging provides a detailed, quantitative assessment of tissue properties. ^{2 3 4 9 10}

What is the purpose of this trial?

The purpose of this research study is to use a new imaging technique called Magnetic Resonance (MR) Elastography to create new imaging parameters to measure the mechanical properties of myofascial tissues that can be used to assess the impaired myofascial interface in myofascial pain syndrome (MPS).

Research Team

Ziying Yin, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Pregnancy or breastfeeding

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography (MRE) for measurement of muscle stiffness of the shoulder: feasibility with a 3 T MRI system. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography: a review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Identification and quantification of myofascial taut bands with magnetic resonance elastography. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Quantification of Myofascial Taut Bands. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography: non-invasive mapping of tissue elasticity. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

[Optimization of External Driver Amplitude in Magnetic Resonance Elastography of the Liver: Relationship between Appropriate External Driver Amplitude and Indicators of Physical Constitution]. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Vibration safety limits for magnetic resonance elastography. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Quality Control of Magnetic Resonance Elastography Using Percent Measurable Liver Volume Estimation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Elastography of the Brain. [2022]

10. China pubmed.ncbi.nlm.nih.gov

Exploration of highly accelerated magnetic resonance elastography using high-density array coils. [2020]