Chronic Low-back Pain Clinical Trial
Official title:
Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
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
Status | Recruiting |
Enrollment | 170 |
Est. completion date | December 30, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Kauffman Medical Building | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of one of four MP-related categories | Participants to be diagnosed as normal, MP without TPs, MP with latent TPs, and MP with active TPs as determined by standardized clinical examinations. | Study Visit 1 (week 1) | |
Secondary | Presence of Substantial MP | The presence of substantial MP (e.g., # active TPs and pressure pain threshold below 6.5 N/cm2) as determined by the standardized clinical examinations. | Study Visit 1 (week 1) - Study Visit 2 (week 2) |
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