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Enrolling by invitation NCT05604066

Magnetic Resonance Elastography of Myofascial Pain Syndrome

No phase Interventional Myofascial Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance (MR) Elastography, MRI structural imaging.
Who it may be relevant to
Registry conditions: Myofascial Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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
  • Diagnostic test MRI structural imaging
    MRI structural imaging will be done at the same time as MR elastography.

Primary outcome measures

  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT05604066 · 22-007647 · R61AT012185

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗