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Magnetic Resonance Elastography of Myofascial Pain Syndrome

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05604066
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ziying Yin, Ph.D.
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Myofascial Pain
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Patients with myofascial-related pain diseases

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

Experimental: Healthy controls without myofascial-related pain diseases

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Minnesota, Rochester, Minnesota

Status

Address

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

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