Kauffman Medical Building
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
NCT Number: NCT07133139
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.
Interested in participating?
Request Info20 year–70 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: 1 week after treatment at the 2nd scan session
Relationships between changes in the biomarker and changes in the clinical condition
Time frame: 1 week after treatment at the 2nd exam session
relationships between changes in the biomarker and the quantitative measures on the structured clinical exam
Time frame: 3 days after treatment
0-10 average pain intensity over the past 7 days. 0=no pain, 10=worst possible pain
Time frame: 3 days after treatment
Pain Interference T score on the PROMIS short form, range 0-100, lower score= less pain interference
Interested in participating?
Request InfoAjay Wasan, MD, Msc
Other
Treatment Validation of an Ultrasound Imaging Biomarker for Myofascial Pain
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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