RecruitingNot Applicable

Treatment Validation for Myofascial Pain

United States80 participantsStarted 2025-10-06

Plain-language summary

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.

Who can participate

Age range

20 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group.

Timeframe: 1 week after treatment at the 2nd scan session

Correlations between changes in the biomarker and changes in the clinical assessment of myofascial pain: tender points, trigger points, and pressure algometry.

Timeframe: 1 week after treatment at the 2nd exam session

Trial details

NCT IDNCT07133139

SponsorAjay Wasan, MD, Msc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Ajay Wasan, MD, MSc

412-665-8048 wasanad@upmc.edu

View on ClinicalTrials.gov More Chronic Low-back Pain (cLBP) trials