Magnetic Resonance Elastography of Myofascial Pain Syndrome

Not Applicable

• Conditions: Myofascial Pain
• Interventions: Diagnostic Test: Magnetic Resonance (MR) Elastography; Diagnostic Test: MRI structural imaging

• Registration Number: NCT05604066
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-03
• Study Start: 2023-04-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-18
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 106

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with myofascial-related pain diseases	Magnetic Resonance (MR) Elastography	Subjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.
Patients with myofascial-related pain diseases	MRI structural imaging	Subjects diagnosed with myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.
Healthy controls without myofascial-related pain diseases	Magnetic Resonance (MR) Elastography	Subjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.
Healthy controls without myofascial-related pain diseases	MRI structural imaging	Subjects without myofascial-related pain disease will receive the research MRI imaging including MR elastography and MRI structural imaging.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States