NCT07133139

Treatment Validation for Myofascial Pain

Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ajay Wasan, MD, Msc · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Low-back Pain (cLBP)
• Myofacial Pain

Interventions

Type	Name	Description
DEVICE	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
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2025-08-20
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study