Ultrasound Imaging for Myofascial Pain
CompletedNCT05928884
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
- Conditions
- Chronic Low-back Pain
- Myofascial Pain
- Interventions
- Other: There is no intervention. It is a phenotyping study only
- Sponsor
- University of Pittsburgh
- Collaborators
- National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2023-10-01
- Primary completion
- 2026-09-30
- Sex
- All
- Age range
- from 20 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05928884