Multi-modal Imaging of Myofascial Pain

Study Purpose

The goal of this study is to develop new imaging biomarkers for quantitative assessments of myofascial pain.

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 - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Healthy Volunteer

Inclusion Criteria:

1. Absence of a history of chronic pain in the targeted anatomical location (i.e., neck and shoulder) that had limited activities of daily living or work. 2. A numerical current pain index of lower than 0.5 according to initial assessment with visual analog scale. 3. Able to understand the goal of the project and give informed consent. Healthy Volunteer

Exclusion Criteria:

1. Pregnancy or breastfeeding. 2. Contraindication to MRI. 3. Previous severe/acute neck or shoulder injury. 4. Previous neck or shoulder surgery. 5. Neck or shoulder deformities. 6. Inability to provide consent. Myofascial Pain Patient

Inclusion Criteria:

1. Between the ages of 18 and 60 years old. 2. Neck and/or shoulder pain, unilateral or bilateral. 3. Duration of symptoms for longer than 4 weeks. 4. Pain scale at the active state higher than 4 according to initial assessment with visual analog scale. 5. Presence of active trigger point(s) according to palpation and/or presence of taut band. Myofascial Pain Patient

Exclusion Criteria:

1. Recent history of trauma to the neck (e.g., whiplash) 2. Acute cervical radiculopathy. 3. Acute cervical spine pain component or acute cervical spinal pathology Presence of neuromuscular pathologies or inflammatory muscle diseases (e.g., dermatomyositis) 4. Systemic disease with diffuse body pain (e.g., system lupus erythematosus and and thyroid disease) 5. Peripheral neuropathy. 6. Cancer-related pain. 7. Pregnancy, coagulopathy, fever, general/local infection at the pain site, substance abuse, peripheral neuropathy, or any other diseases that may account for signs and symptoms mimicking myofascial pain. 8. Contraindication to MRI.

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.	NCT06036524
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.	Washington University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myofascial Pain

Additional Details

This study aims to develop a multi-modal, multi-parametric, multi-scale imaging of the human myofascial unit by combining magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging and sensing. Participants (half with active neck/shoulder/back pain, and half healthy controls) will be recruited from pain management clinics and Volunteer for Health, or will be referred by Dr. Xioabin Yi. They will undergo all three imaging techniques and complete a number of patient questionnaires over the course of a single study visit. The study team will then identify candidate biomarkers capable of differentiating between healthy (no myofascial pain) and those with active pain to target in a future clinical trial.

Arms & Interventions

Arms

Experimental: Multi-modal imaging of myofascial pain

Participants with and without myofascial-related pain disease will receive multi-modal, multi-parametric, multi-scale imaging, including magnetic resonance imaging, surface electromyography, and fiber-optic imaging and sensing.

Interventions

Diagnostic Test: - Multi-modal, multi-parametric, multiscale imaging of the myofascial unit

Study Participants will undergo four study procedures at one visit, including magnetic resonance imaging (MRI), surface electromyography (sEMG), fiber-optic imaging and sensing, and questionnaires.

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.

Washington University, Saint Louis, Missouri

Status

Recruiting

Address

Washington University

Saint Louis, Missouri, 63110

Site Contact

Robin Haverman

[email protected]

314-747-1624

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