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NCT Number: NCT07133139

Treatment Validation for Myofascial Pain

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kauffman Medical Building

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Ajay Wasan, MD, MSc

SUB_INVESTIGATOR

Gwendolyn Sowa, MD, PhD

SUB_INVESTIGATOR

Jiantao Pu, PhD

SUB_INVESTIGATOR

Kang Kim, PhD

PRINCIPAL_INVESTIGATOR

Zhiyu Sheng, PhD

CONTACT

[email protected]

917-929-3047

About this study

The goal of this clinical trial is to see if a special body measurement biomarker (called the NUN biomarker) can show changes after dry needling treatment and if it can predict who will get the most pain relief. The study focuses on adults with chronic low back pain (cLBP) that also has a muscle pain (myofascial pain, MP) component.

The main questions it aims to answer are:

  • Does the NUN biomarker go down after dry needling when muscle pain gets better?
  • Can the biomarker predict who will feel better after treatment?
  • Do people with higher biomarker levels at the start respond better to dry needling than to a fake (sham) treatment?

Investigators will compare real dry needling to sham dry needling (fake treatment) to see if the biomarker changes more with real treatment and if this matches pain relief.

Participants will:

  • Get either real dry needling or sham dry needling in a single-blinded setup (participant won't know which one they're getting).
  • Have ultrasound imaging to measure the biomarker before and after treatment.
  • Take a pressure pain test to see how sensitive their muscles are.
  • Report their pain levels after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    Relationships between changes in the biomarker and changes in the clinical condition

  2. 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

    relationships between changes in the biomarker and the quantitative measures on the structured clinical exam

Secondary outcomes

  1. Average Pain Intensity

    Time frame: 3 days after treatment

    0-10 average pain intensity over the past 7 days. 0=no pain, 10=worst possible pain

  2. Pain interference

    Time frame: 3 days after treatment

    Pain Interference T score on the PROMIS short form, range 0-100, lower score= less pain interference

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Wasan, MD, MSc

CONTACT

[email protected]

412-665-8048

Kunal Lohana, MPH

CONTACT

[email protected]

412-648-4925

Sponsors and collaborators

Lead sponsor

Ajay Wasan, MD, Msc

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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