Treatment Validation for Myofascial Pain

Ajay Wasan, MD, Msc

Status: Enrolling

Conditions: Myofacial Pain; Chronic Low-back Pain (cLBP)

Treatments: Device: Dry Needling; Other: NUN Biomarker; Device: Sham Dry Needling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07133139

R61AT012282 (U.S. NIH Grant/Contract)

STUDY25060095

Details and patient eligibility

About

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.

Full description

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:

1. Does the NUN biomarker go down after dry needling when muscle pain gets better?
2. Can the biomarker predict who will feel better after treatment?
3. 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:

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Dry needling

Active Comparator group

Treatment:

Other: NUN Biomarker

Device: Dry Needling

Sham Dry Needling

Sham Comparator group

Treatment:

Device: Sham Dry Needling

Other: NUN Biomarker