Clinical Trial Finder

Ultrasound Imaging for Myofascial Pain

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 20 Years - 70 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05928884
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kang Kim, PhD
Principal Investigator Affiliation University of Pittsburgh
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Chronic Low-back Pain, Myofascial Pain
Additional Details

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).

Arms & Interventions

Arms

: Healthy Normals

Participants with no chronic pain over a three-year timeframe.

: MP without TPs

Participants with chronic low back pain who are classified as having myofascial pain and no trigger points.

: MP with latent TPs

Participants with chronic low back pain who are classified as having myofascial pain and latent trigger points.

: MP with active TPs

Participants with chronic low back pain who are classified as having myofascial pain and active trigger points.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kauffman Medical Building, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Kauffman Medical Building

Pittsburgh, Pennsylvania, 15213

Site Contact

Zhiyu Sheng, PhD

[email protected]

917-929-3047

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