Treatment Validation for Myofascial Pain

Conditions

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

Eligibility Criteria

Sex

ALL

Age

20 Years - 70 Years

Healthy Volunteers

Not accepted

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
• 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.

Study Details

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.

Key Dates

Start date

Oct 6, 2025

Status verified

Dec 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Dry needling
• Sham Comparator: Sham Dry Needling

Primary Outcome Measure

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 ]

Central Contacts

• Ajay Wasan, MD, MSc
  412-665-8048
  [email protected]
• Kunal Lohana, MPH
  412-648-4925
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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