search
Back to results

Magnetic Resonance Elastography of Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance (MR) Elastography
MRI structural imaging
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myofascial Pain focused on measuring Magnetic Resonance Imaging (MRI), Magnetic Resonance Elastography (MRE)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with myofascial-related pain diseases

Healthy controls without myofascial-related pain diseases

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 24, 2022
Last Updated
May 16, 2023
Sponsor
Mayo Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT05604066
Brief Title
Magnetic Resonance Elastography of Myofascial Pain Syndrome
Official Title
Magnetic Resonance Elastography of Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain
Keywords
Magnetic Resonance Imaging (MRI), Magnetic Resonance Elastography (MRE)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with myofascial-related pain diseases
Arm Type
Experimental
Arm Description
Subjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.
Arm Title
Healthy controls without myofascial-related pain diseases
Arm Type
Experimental
Arm Description
Subjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance (MR) Elastography
Other Intervention Name(s)
MRE
Intervention Description
Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI structural imaging
Other Intervention Name(s)
MRI
Intervention Description
MRI structural imaging will be done at the same time as MR elastography.
Primary Outcome Measure Information:
Title
The fascia plane mobility assessed by MR Elastography-based normalized octahedral shear strain (NOSS) measurements
Description
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.
Time Frame
baseline measures through the study completion (3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziying Yin, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Magnetic Resonance Elastography of Myofascial Pain Syndrome

We'll reach out to this number within 24 hrs