Kauffman Medical Building
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT05928884
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
Looking for future studies?
Notify Me20 year–70 year
All sexes
Observational
Pittsburgh, Pennsylvania, 15213, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion/Exclusion Criteria for Healthy Normals (n=40):
Inclusion criteria
CLBP:
Exclusion criteria
CLBP:
See above, this is only a phenotyping study but NIH required us to register it as a trial.
Time frame: 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.
Time frame: 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.
University of Pittsburgh
Other
Development and Validation of a Noninvasive Multimodal Ultrasound-Based Imaging Biomarker for Myofascial Pain
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06931158
Chronic Low-back Pain, Chronic Pain
Providence, Rhode Island, United States
View Trial DetailsNCT04980612
Chronic Low-back Pain, Neurologic Manifestations
San Francisco, California, United States
View Trial DetailsNCT07395102
Chronic Low-back Pain
Jakarta Pusat, DKI Jakarta, Indonesia
View Trial DetailsNCT06471998
Chronic Low-back Pain
Marseille, France
View Trial Details