Recruiting

Dry Needling

Sponsor:

Ajay Wasan, MD, Msc

Code:

NCT07133139

Conditions

Chronic Low-back Pain (cLBP)

Myofacial Pain

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Dry Needling

Sham Dry Needling

NUN Biomarker

Study Details

Brief 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.

Conditions

Chronic Low-back Pain (cLBP)

Myofacial Pain

Study ID

NCT07133139

Start date

Oct 6, 2025

Status verified date

Dec, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Dry needling

sham comparator: Sham Dry Needling

Interventions

Dry Needling

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

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

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.

Primary outcome measure

  • Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group. [ Time Frame: 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. [ Time Frame: 1 week after treatment at the 2nd exam session ]

Central Contacts and Locations

Central contacts

Ajay Wasan, MD, MSc

412-665-8048wasanad@upmc.edu

Kunal Lohana, MPH

412-648-4925kul31@pitt.edu

Locations

Kauffman Medical Building

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Zhiyu Sheng, PhD

917-929-3047ZHS41@pitt.edu

Principal Investigator:

Kang Kim, PhD

More Information

Sponsor

Ajay Wasan, MD, Msc

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ajay Wasan, MD, Msc on 2025-12-24.