Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-10-06
2027-08-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Dry needling
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
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.
Sham Dry Needling
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.
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.
Interventions
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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
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
70 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Ajay Wasan, MD, Msc
OTHER
Responsible Party
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Ajay Wasan, MD, Msc
Professor
Principal Investigators
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Kang Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Ajay Wasan, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Kauffman Medical Building
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Zhiyu Sheng, PhD
Role: primary
Other Identifiers
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STUDY25060095
Identifier Type: -
Identifier Source: org_study_id