Ultrasound Imaging for Myofascial Pain
- Conditions
- Chronic Low-back PainMyofascial Pain
- Interventions
- Other: There is no intervention. It is a phenotyping study only
- Registration Number
- NCT05928884
- Lead Sponsor
- University of Pittsburgh
- Brief 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
- Detailed Description
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Normals There is no intervention. It is a phenotyping study only Participants with no chronic pain over a three-year timeframe. MP without TPs There is no intervention. It is a phenotyping study only Participants with chronic low back pain who are classified as having myofascial pain and no trigger points. MP with latent TPs There is no intervention. It is a phenotyping study only Participants with chronic low back pain who are classified as having myofascial pain and latent trigger points. MP with active TPs There is no intervention. It is a phenotyping study only Participants with chronic low back pain who are classified as having myofascial pain and active trigger points.
- Primary Outcome Measures
Name Time Method Diagnosis of one of four MP-related categories Study Visit 1 (week 1) Participants to be diagnosed as normal, MP without TPs, MP with latent TPs, and MP with active TPs as determined by standardized clinical examinations.
- Secondary Outcome Measures
Name Time Method Presence of Substantial MP Study Visit 1 (week 1) - Study Visit 2 (week 2) 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.
Trial Locations
- Locations (1)
Kauffman Medical Building
🇺🇸Pittsburgh, Pennsylvania, United States