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Treatment Validation for Myofascial Pain

Sponsor: Ajay Wasan, MD, Msc • ClinicalTrials.gov ID: NCT07133139

Registry updated: 2026-10-01

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Description

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.

Interventions

Dry Needling (Device)
The examiner will use the "repeated tapping" technique of Travel and Simmons in the active condition in the painful tender points and TPs. In the sham treatment, the needle tip retracts when pushed against the skin (like a ballpoint pen), and the subject feels a pointy object on their skin, which does not penetrate. Prior studies have shown that this is a credible placebo condition. Prior studies have also shown that one dry needling session is effective at least temporarily for 1-2 weeks, AND that US correlates of TPs improve as well
Sham Dry Needling (Device)
Half of the subjects will receive a sham needle instead which puts pressure on the skin but does not penetrate the skin (like a ballpoint pen with the tip retracted pushing on the skin). Since manual pressure over myofascial tender and trigger points is also an accepted treatment, the sham procedure could also be therapeutic, although we do not think it will be very effective.
NUN Biomarker (Other)
A NUN biomarker measurement means checking the level of a certain substance (the "NUN" biomarker) in your body that can give investigators clues about your condition. Measuring the NUN biomarker helps investigators see if a treatment is working or if your condition is changing.

Eligibility criteria

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.

Conditions

Chronic Low-back Pain (cLBP) Myofacial Pain

Locations

Kauffman Medical Building — Pittsburgh, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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