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Magnetic Resonance Elastography of Myofascial Pain Syndrome

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05604066
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
106
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic Resonance (MR) Elastography
  • Diagnostic Test: MRI structural imaging
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
106 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Magnetic Resonance Elastography of Myofascial Pain Syndrome
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ziying Yin, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05604066
    Other Study ID Numbers:
    • 22-007647
    • R61AT012185
    First Posted:
    Nov 3, 2022
    Last Update Posted:
    Dec 29, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ziying Yin, Principal Investigator, Mayo Clinic
    Magnetic Resonance Imaging (MRI)
    Magnetic Resonance Elastography (MRE)
    Additional relevant MeSH terms:
    Myofascial Pain Syndromes
    Fibromyalgia

    Study Results

    No Results Posted as of Dec 29, 2022