Not Yet RecruitingNot Applicable

Pilot MRI Study on Osteopathic Manipulation for Myofascial Pain Syndrome

20 participantsStarted 2024-08-31

Plain-language summary

The goal of this clinical trial is to conduct MRI studies on adults with myofascial pain syndrome (MPS) to identify important MRI biomarkers that respond to OMT (osteopathic manipulation therapy) and investigate the feasibility of implementing MRI study and OMT in this population. The main outcomes of the study include: * Determine whether biomarkers measured by MRI can differentiate normal tissues and MTrP (myofascial trigger point). * Test the responsiveness of the biomarkers identified by MRI to the proposed intervention, OMT, in patients with MPS of the upper back. Researchers will compare participants who will receive one session of OMT (Group 1 - Experimental Condition) and participants who will not receive any treatment (Group 2 - Control Condition) to see how the MRI-identified biomarkers respond to the intervention. Participants will complete the following: * Clinical screening * MRI measures * Battery of self-report surveys * Clinical/Physical Function Assessment

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * MPS of the upper back with MTrPs as specified by Travell and Simons, with the confirmation of ultrasound procedure. * Normal neurological examination including manual muscle testing, sensory exam, and deep tendon reflexes. * English-speaking. * Age 18 - 64 and reside in the community. Exclusion Criteria: * Malignancy. * Major psychiatric disorders, such as bipolar disorder and depression. * Cognitive impairment * Skin lesion(s) on the shoulders and upper back. * Systematic pain condition, such as Fibromyalgia. * Previous surgical procedures in the spine, shoulder, and/or back within six months. * Pregnancy. * BMI of 40 or higher. * Any health conditions that prevent participants from performing the experimental procedure * Any contraindications of MRI procedure such as implantable cardiac devices (pacemakers, defibrillator, etc.), aneurysm clips, or metallic shoulder and/or spinal cord implants or screws.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRI Biomarkers - Structural MRI

Timeframe: For experimental group (Group 1): Outcomes will be assessed at Time 1 and Time 2 within the 4 hour duration; For no intervention group (Group 2): Outcomes will be assessed at Time 1 within the 4 hour duration.

MRI Biomarkers - Diffusion Tensor MRI (DTI)

fMRI

Trial details

NCT IDNCT06538727

SponsorAuburn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

Contact for this trial

Pao-Feng Tsai, PhD

334-844-6807 pzt0022@auburn.edu

View on ClinicalTrials.gov More Myofascial Pain Syndrome trials