Magnetic Resonance Elastography of Myofascial Pain Syndrome

May 16, 2023 updated by: Ziying Yin, Mayo Clinic
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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Healthy Volunteer 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.

Healthy Volunteer 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.

Myofascial-Related Pain Patient Inclusion Criteria:

  • 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

Myofascial-Related Pain Patient Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: Magnetic Resonance (MR) Elastography
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
Other Names:
  • MRE
Diagnostic test: MRI structural imaging
MRI structural imaging will be done at the same time as MR elastography.
Other Names:
  • MRI
Experimental: 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.
Diagnostic test: Magnetic Resonance (MR) Elastography
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
Other Names:
  • MRE
Diagnostic test: MRI structural imaging
MRI structural imaging will be done at the same time as MR elastography.
Other Names:
  • MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements
Time Frame: baseline measures through the study completion (3 years)
In response to an external shear force, the fascial layers that surround and separate muscles can deform or slide relative to each other, depending on the fascial plane's mobility. An adhesive interface that experiences a shear force will exhibit shear displacement continuity (i.e., small shear strain) across the interface, while a nonadhesive interface may slip rather than deform, which causes a discontinuity in displacement (i.e., large shear strain). For the targeted fascia plane in low back and legs, the normalized octahedral shear strain (NOSS) will be computed from the shear displacement data measured from MRE to assess the fascia plane mobility. The primary outcome measure is the difference in the fascia plane mobility on MR elastography between patients with myofascial-related pain diseases and healthy controls without myofascial-related pain diseases.
baseline measures through the study completion (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Ziying Yin, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2023

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-007647
  • R61AT012185 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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