Ultrasound Imaging for Myofascial Pain

NCT05928884 | Completed

• 2 other identifiers: STUDY220900141R61AT012282-01
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low-back Pain; Myofascial Pain

Keywords

Ultrasound; Trigger Points; Lumbar Myofascial Pain; Thoracolumbar Fascia; Multifidus Muscle; Neural Understanding Network

Outcome Measures

Primary Outcomes (1)

• Diagnosis of one of four MP-related categories

  Participants to be diagnosed as normal, MP without TPs, MP with latent TPs, and MP with active TPs as determined by standardized clinical examinations.

  Study Visit 1 (week 1)

Secondary Outcomes (1)

• Presence of Substantial MP

  Study Visit 1 (week 1) - Study Visit 2 (week 2)

Study Arms (4)

Healthy Normals

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

Other: There is no intervention. It is a phenotyping study only

MP without TPs

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

Other: There is no intervention. It is a phenotyping study only

MP with latent TPs

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

Other: There is no intervention. It is a phenotyping study only

MP with active TPs

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

Other: There is no intervention. It is a phenotyping study only

Interventions

There is no intervention. It is a phenotyping study only OTHER

See above, this is only a phenotyping study but NIH required us to register it as a trial.

Healthy Normals; MP with active TPs; MP with latent TPs; MP without TPs

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators are including healthy normal and cLBP subjects from ages 20 to 70.

You may not qualify if:

• 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.
• 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).
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Kauffman Medical Building

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Kang Kim, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 3, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)