Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05928884
Study type Observational
Source University of Pittsburgh
Contact Ajay Wasan, MD, MSc
Phone 4126658048
Email wasanad@upmc.edu
Status Recruiting
Phase
Start date October 1, 2023
Completion date December 30, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05963451 - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed NCT04283370 - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain N/A
Completed NCT04824547 - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals N/A
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT05780021 - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation N/A
Completed NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Completed NCT04530071 - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Phase 1/Phase 2
Not yet recruiting NCT06080464 - Clinician Satisfaction With the VERABANDâ„¢ N/A
Not yet recruiting NCT06347328 - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management N/A
Recruiting NCT05724160 - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain N/A
Recruiting NCT06030128 - Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults N/A
Recruiting NCT05846087 - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia N/A
Active, not recruiting NCT05396014 - The BEST Trial: Biomarkers for Evaluating Spine Treatments Phase 4
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Completed NCT05512338 - Motivation and Adherence to Exercise Recommendations N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Completed NCT05120921 - Osteopathic Single CAse Research for Patients With Chronic Low Back Pain N/A