Chronic Low-back Pain (cLBP)NCT07133139
Treatment Validation for Myofascial Pain
A study testing Dry Needling and NUN Biomarker in people with Chronic Low-back Pain (cLBP) and Myofacial Pain, run by Ajay Wasan, MD, Msc at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP), Myofacial Pain
- What is being tested?
- Dry Needling and NUN Biomarker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- NO HISTORY of receiving dry needling, to improve the effectiveness of the blind;
- Demonstration of healthcare seeking at some point for LBP.
Who cannot join
- 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;
- Non-ambulatory status;
- Not able to complete the questionnaire
- Currently pregnant or have intentions to become pregnant during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kauffman Medical Building
Pittsburgh, Pennsylvania, 15213
Zhiyu Sheng, PhD, 917-929-3047, ZHS41@pitt.edu
Kang Kim, PhD
About this study
Official title: Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain
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.
Read the 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:
- Does the NUN biomarker go down after dry needling when muscle pain gets better?
- Can the biomarker predict who will feel better after treatment?
- 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:
- Get either real dry needling or sham dry needling in a single-blinded setup (participant won't know which one they're getting).
- Have ultrasound imaging to measure the biomarker before and after treatment.
- Take a pressure pain test to see how sensitive their muscles are.
- Report their pain levels after treatment.
- Conditions
- Chronic Low-back Pain (cLBP), Myofacial Pain
- Being tested
- Dry Needling, Sham Dry Needling, NUN Biomarker
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
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 NeedlingDevice
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 BiomarkerOther
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 group | Role | What they receive |
|---|---|---|
| Dry needling | Active comparator | Not described Receives: Device: Dry Needling; Other: NUN Biomarker |
| Sham Dry Needling | Sham comparator | Not described Receives: Device: Sham Dry Needling; Other: NUN Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week after treatment at the 2nd scan session
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
Measured: 1 week after treatment at the 2nd exam session
Secondary outcomes (2)
Average Pain Intensity
0-10 average pain intensity over the past 7 days. 0=no pain, 10=worst possible pain
Measured: 3 days after treatment
Pain interference
Pain Interference T score on the PROMIS short form, range 0-100, lower score= less pain interference
Measured: 3 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start6 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajay Wasan, MD, Msc
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Ajay Wasan, MD, Msc, University of Pittsburgh
- Investigators
- Kang Kim, PhD, Principal investigator, University of PittsburghAjay Wasan, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133139
- Sponsor's protocol ID
- STUDY25060095
- Other IDs
- R33AT012282
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A de-identified dataset can be shared with investigators upon request