Treatment Validation for Myofascial Pain

NCT07133139 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY25060095R61AT012282
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Significant decrease in NUN biomarker levels in the dry needling treatment group compared to the sham (placebo) group.

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

  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.

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

  1 week after treatment at the 2nd exam session

Secondary Outcomes (2)

• Average Pain Intensity

  3 days after treatment

• Pain interference

  3 days after treatment

Study Arms (2)

Dry needling

ACTIVE COMPARATOR

Device: Dry Needling; Other: NUN Biomarker

Sham Dry Needling

SHAM COMPARATOR

Device: Sham Dry Needling; Other: NUN Biomarker

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

Dry needling

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.

Sham Dry Needling

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.

Dry needling; Sham Dry Needling

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajay Wasan, MD, Msc: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Kauffman Medical Building

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Facial Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Kang Kim, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Ajay Wasan, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Wasan, MD, MSc

CONTACT

412-665-8048; wasanad@upmc.edu

Kunal Lohana, MPH

CONTACT

412-648-4925; kul31@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 20, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available after publication of the primary paper

Locations

US (1)