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| ID | Type | Description | Link |
|---|---|---|---|
| R61AT012282 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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:
Investigators will compare real and fake (sham) dry needling using ultrasound, muscle pressure tests, and pain reports before and after treatment.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry needling | Active Comparator |
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| Sham Dry Needling | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 week after treatment at the 2nd exam session |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Intensity | 0-10 average pain intensity over the past 7 days. 0=no pain, 10=worst possible pain | 3 days after treatment |
| Pain interference | Pain Interference T score on the PROMIS short form, range 0-100, lower score= less pain interference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ajay Wasan, MD, MSc | Contact | 412-665-8048 | wasanad@upmc.edu | |
| Kunal Lohana, MPH | Contact | 412-648-4925 | kul31@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kang Kim, PhD | University of Pittsburgh | Principal Investigator |
| Ajay Wasan, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kauffman Medical Building | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
A de-identified dataset can be shared with investigators upon request
Available after publication of the primary paper
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| 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. |
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| 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. |
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| 3 days after treatment |