Magnetic Resonance Elastography of Myofascial Pain Syndrome

NCT ID: NCT05604066

Last Updated: 2025-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-13

Study Completion Date

2027-08-31

Brief Summary

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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).

Detailed Description

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This is observational research that aims to develop an MRI-based imaging technique (MRE) to quantitatively assess the myofascial tissue properties in healthy subjects and patients with relevant pain conditions. Healthy volunteers and patients with MPS will be recruited to undergo MRI along with MR elastography.

Conditions

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Myofascial Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a two-phase NIH-awarded study. The first R61 phase (currently awarded) is an observational study with one control group and one patient group. The second R33 phase is a pilot clinical trial, which will be awarded by the end of the R61 phase. The study design provided here is for R61 only.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with myofascial-related pain diseases

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

Group Type EXPERIMENTAL

Magnetic Resonance (MR) Elastography

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues

MRI structural imaging

Intervention Type DIAGNOSTIC_TEST

MRI structural imaging will be done at the same time as MR elastography.

Healthy controls without myofascial-related pain diseases

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

Group Type EXPERIMENTAL

Magnetic Resonance (MR) Elastography

Intervention Type DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues

MRI structural imaging

Intervention Type DIAGNOSTIC_TEST

MRI structural imaging will be done at the same time as MR elastography.

Interventions

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Magnetic Resonance (MR) Elastography

Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues

Intervention Type DIAGNOSTIC_TEST

MRI structural imaging

MRI structural imaging will be done at the same time as MR elastography.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MRE MRI

Eligibility Criteria

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Inclusion Criteria

* Absence of a history of chronic pain in the targeted anatomical location (i.e., lower back and low extremities) that had limited activities of daily living or work
* A numerical current pain index of less than 0.5 (on a 10-point Visual Analog Scale)
* Able to understand the goal of the project and give informed consent.


* A history of chronic low back or leg pain (the targeted location will be determined based on the findings in Aim 1) for at least 3 months. (Measured by patient history and physical exam)
* A palpable taut band or nodule within the skeletal muscle
* Hypersensitive tender spot within the taut band
* Recognition of current pain complaint by pressure on the tender nodule/taut band
* Painful limit to the full stretch range of motion

Exclusion Criteria

* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous severe/acute back or low extremity injury (including fracture)
* Previous back or low extremity surgery
* Back and lower limb deformities
* Inability to provide consent.


* Pregnancy or breastfeeding
* Any contraindication to an MRI exam
* Previous therapy in the area to be treated within 6 months
* Previous severe back or low extremity injury (including fracture) or surgery
* Any neurological conditions or active systemic disease (e.g. diabetes, peripheral vascular disease, cancer, rheumatoid arthritis) that impaired sensation/pain perception
* Severe osteoarthritis
* Skin injuries in the area to be treated
* Inability to provide consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ziying Yin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziying Yin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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R61AT012185

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-007647

Identifier Type: -

Identifier Source: org_study_id

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