Treatment Validation for Myofascial Pain

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

Interventions

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Ajay Wasan, MD, Msc

  lead OTHER

Principal Investigators

• Kang Kim, PhD · University of Pittsburgh

• Ajay Wasan, MD, MSc · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-06

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations