Magnetic Resonance Elastography of Myofascial Pain Syndrome

Mayo Clinic

Status: Invitation-only

Conditions: Myofascial Pain

Treatments: Diagnostic Test: MRI structural imaging; Diagnostic Test: Magnetic Resonance (MR) Elastography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05604066

22-007647

R61AT012185 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Patients with myofascial-related pain diseases

Experimental group

Description:

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

Treatment:

Diagnostic Test: Magnetic Resonance (MR) Elastography

Diagnostic Test: MRI structural imaging

Healthy controls without myofascial-related pain diseases

Experimental group

Description:

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

Treatment:

Diagnostic Test: Magnetic Resonance (MR) Elastography

Diagnostic Test: MRI structural imaging