Ultrasound Imaging for Myofascial Pain (NCT05928884) | Clinical Trial Compass
CompletedNot Applicable
Ultrasound Imaging for Myofascial Pain
United States124 participantsStarted 2023-10-01
Plain-language summary
The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
* Will the deep learning-based marker reliably identify subjects from the 4 different groups: healthy, MP without trigger points, MP with latent trigger points, and MP with active trigger points?
* Will the deep learning-based marker accurately classify/predict the severity of MP in subjects with cLBP?
Participants in the healthy group will be asked to do the following tasks:
* Consent/Enrollment
* Measure Height/Weight
* Complete Questionnaires on REDCap
* Participate in Ultrasound Imaging Experiment Sessions
Participants in the chronic low back pain group will be asked to do the following tasks:
* Consent/Enrollment
* Complete Questionnaires on REDCap
* Measure Height/Weight
* Undergo a Standardized Clinical Exam
* Participate in Ultrasound Imaging Experiment Sessions
Who can participate
Age range
20 Years – 70 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/Exclusion Criteria for Healthy Normals (n=40):
* No history of chronic low back pain, myofascial pain of the neck or shoulders, or fibromyalgia.
* Ages 20-70 to be age appropriate to the cLBP subjects. The investigators will recruit 10 subjects per age decile (10 subjects ages 30-39 yrs., etc.).
* Any clinically unstable systemic illness that is judged to interfere
* with the trial
* Non-ambulatory status
* Not able to complete the questionnaires.
Inclusion Criteria CLBP:
* Age range 20-70 so that the age distribution is likely to roughly match the healthy normals
* Predominantly axial cLBP meeting the NIH definition of cLBP (at least 3 months on a daily basis) with a MP component (determined by a standardized clinical exam)
* Average pain score of \> 3/10, with low back pain being the primary pain site
* cLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs).
Exclusion Criteria CLBP:
* Back surgery within the past year
* Active worker's compensation or litigation claims since these patients are more likely to have exaggerated pain behavior
* New pain treatments within 2 weeks of enrollment
* Any clinically unstable systemic illness that is judged to interfere with the trial
* Non-ambulatory status
* Not able to complete the questionnaires.
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.