Testing the NUN biomarker to guide dry needling for myofascial low back pain.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic axial low back pain and a myofascial pain component are randomized to receive either real or sham dry needling in a single-blinded design. Investigators measure the NUN biomarker with ultrasound imaging before and after a treatment session, perform pressure pain testing, and collect patient-reported pain scores. The main aims are to see whether the biomarker falls when pain improves, whether baseline biomarker levels predict who benefits, and whether changes differ between real and sham needling. All procedures require in-person visits for imaging and needling at the study site.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kauffman Medical Building
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kang Kim, PhD — University of Pittsburgh
• Study coordinator: Ajay Wasan, MD, MSc
• Email: wasanad@upmc.edu
• Phone: 412-665-8048

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.