Using ultrasound to identify myofascial pain in the lower back
Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
This study is testing if ultrasound can help identify and understand myofascial pain in the lower back for people who have chronic pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05928884 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a biomarker for lumbar myofascial pain using ultrasound imaging of the lumbar muscles and fascia. The researchers will employ advanced machine learning techniques to classify subjects into different groups based on their pain characteristics and severity. Participants will undergo ultrasound imaging and complete questionnaires to gather data on their condition. The study seeks to create a reliable and practical tool for diagnosing and predicting myofascial pain in individuals with chronic low back pain.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20-70 with chronic low back pain and a myofascial pain component.
Not a fit: Patients with a history of chronic low back pain, myofascial pain in other areas, or fibromyalgia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for accurately diagnosing and predicting myofascial pain, leading to better-targeted treatments for patients.
How similar studies have performed: While the use of ultrasound in pain assessment is established, the specific application of deep learning to create a biomarker for myofascial pain is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- Kauffman Medical Building — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kang Kim, PhD — University of Pittsburgh
- Study coordinator: Ajay Wasan, MD, MSc
- Email: wasanad@upmc.edu
- Phone: 4126658048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.