Ultrasound Imaging for Myofascial Pain

Sponsor

University of Pittsburgh (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05928884

Collaborator

National Institutes of Health (NIH) (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH)

170

Enrollment

Location

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain Myofascial Pain

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.