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Enrolling by Invitation

NCT Number: NCT05604066

Magnetic Resonance Elastography of Myofascial Pain Syndrome

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetic Resonance (MR) Elastography

Diagnostic Test

Magnetic resonance imaging (MRI) imaging technique that creates a visual map (Elastogram) to show the stiffness of body tissues

Other names: MRE

MRI structural imaging

Diagnostic Test

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

Other names: MRI

Primary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 3, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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