Health TrialsbyHealthPanel

Treatment Validation for Myofascial Pain

ConditionsChronic Low-back Pain (cLBP)Myofacial Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorAjay Wasan, MD, Msc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Dry needlingActive comparator 2 interventions
Group B: Sham Dry NeedlingSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1 week after treatment at the 2nd scan session
2

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

Time frame
1 week after treatment at the 2nd exam session

Secondary outcomes

1

Average Pain Intensity

0-10 average pain intensity over the past 7 days. 0=no pain, 10=worst possible pain

Time frame
3 days after treatment
2

Pain interference

Pain Interference T score on the PROMIS short form, range 0-100, lower score= less pain interference

Time frame
3 days after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ajay Wasan, MD, Msc

Lead sponsor

University of Pittsburgh

Sponsor institution

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
Apply now