Actively Recruiting
Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain
Led by Ajay Wasan, MD, Msc · Updated on 2025-12-24
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Ajay Wasan, MD, Msc
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to see if a body test called the NUN biomarker can track changes in chronic low back pain after dry needling and predict who will feel better. This study is for adults with chronic low back pain from muscle pain (Myofacial Pain). The main questions are: * Does the biomarker drop when pain improves? * Can it predict who benefits most? * Do higher starting levels mean better results with real dry needling? Investigators will compare real and fake (sham) dry needling using ultrasound, muscle pressure tests, and pain reports before and after treatment.
CONDITIONS
Brief Title
Treatment Validation for Myofascial Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 20-70;
- Predominantly axial LBP (meeting NIH definition of cLBP with daily pain for at least 3 months) with a MP component as determined by the standardized examination for MP;
- 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). Constant radicular pain associated with sensory loss is likely a confounder to dry needling treatment success;
- NO HISTORY of receiving dry needling, to improve the effectiveness of the blind;
- Demonstration of healthcare seeking at some point for LBP.
You will not qualify if you...
- Back surgery within the past six months;
- Active workers' 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 or condition that is judged to interfere with the trial;
- Non-ambulatory status;
- Not able to complete the questionnaire
- Currently pregnant or have intentions to become pregnant during the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kauffman Medical Building
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
A
Ajay Wasan, MD, MSc
K
Kunal Lohana, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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