NCT05928884

Ultrasound Imaging for Myofascial Pain

Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Chronic Low-back Pain
• Myofascial Pain

Interventions

Type	Name	Description
OTHER	There is no intervention. It is a phenotyping study only	See above, this is only a phenotyping study but NIH required us to register it as a trial.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-07-03
• Last updated: 2025-08-06

Locations

1 site across 1 country: United States