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

Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain

This study will try to see if the NUN biomarker changes after dry needling and can predict who with chronic myofascial low back pain will feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT07133139 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 20–70 with predominantly axial chronic low back pain for at least 3 months, a myofascial pain component on exam, average pain above 3/10, no prior dry needling, and meeting Quebec Task Force categories I–III are ideal candidates.

Not a fit: Patients with recent back surgery (within six months), active workers' compensation or litigation, new pain treatments within two weeks, clear neurologic radicular pain with sensory loss, unstable systemic illness, or those outside the age range are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the biomarker could help identify which patients are likely to benefit from dry needling and allow clinicians to track treatment response more objectively.

How similar studies have performed: Prior trials of dry needling for myofascial pain have shown mixed results, and the NUN biomarker is a novel measure that has not been widely validated in large clinical cohorts.

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.

Where this trial is running

Pittsburgh, Pennsylvania

• Kauffman Medical Building — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Kang Kim, PhD — University of Pittsburgh
• Study coordinator: Ajay Wasan, MD, MSc

Conditions Chronic Low-back Pain; Myofacial Pain