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| ID | Type | Description | Link |
|---|---|---|---|
| R33AT012283 | 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 study is to evaluate imaging biomarkers for quantitative assessments of myofascial pain and determine their ability to monitor treatment response and predict clinical outcomes.
This Phase 2 randomized clinical trial builds upon findings from Phase 1, which identified candidate imaging biomarkers of myofascial pain. The study will assess whether these biomarkers can monitor responses to local chemical injection treatment and predict clinical outcomes.
Participants with neck/shoulder pain and the presence of active myofascial trigger points will be referred from pain management clinics or recruited through the Volunteer for Health office. Eligible participants will undergo multi-modal imaging procedures, including magnetic resonance imaging (MRI), surface electromyography (sEMG), and fiber-optic imaging. Participants will then be randomized to receive either chemical injection or dry needling at the identified trigger points.
Over the course of two study visits, spaced approximately two weeks apart, participants will complete imaging procedures and patient-reported outcome questionnaires. The study team will analyze imaging and clinical data to evaluate the capacity of identified biomarkers to detect treatment-related changes and to predict longer-term clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemical Injection | Active Comparator | Local chemical injection at clinician-identified myofascial trigger points. |
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| Dry Needle | Placebo Comparator | Dry needling at clinician-identified myofascial trigger points. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50/50 Mixture of Lidocaine 1% injection + Bupivacaine 0.25% Injectable Solution | Drug | Treatment Group: Receives trigger-point injection with a 50/50 mixture of 1% lidocaine and 0.25% bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Statistical Plan | The statistical analysis will assess the ability of imaging biomarkers to distinguish pathological and physiological differences among participant groups. Imaging biomarkers of the myofascial tissue will be measured for each participant, including tissue stiffness, hydration, inflammation, blood oxygenation and flow, and electrical activity. Group differences in each imaging biomarker will be evaluated independently using Student's t-test or Wilcoxon rank-sum test, as appropriate. Each biomarker will be analyzed and reported separately and will not be combined into a composite measure. We hypothesize that some imaging biomarkers will demonstrate large effect sizes between participant groups. Statistical power will be estimated based on Cohen's d for individual biomarkers. With an expected effect size greater than 0.9, the proposed sample size provides greater than 80% power. Multi-modal imaging is expected to identify biomarkers with strong group differences. | Baseline and follow-up study visits approximately 2 weeks apart (each visit lasting 3-4 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre Guthrie, BS | Contact | 3142732556 | guthriea@wustl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D002045 | Bupivacaine |
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000813 | Anilides |
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| Dry Needling | Procedure | Single session of dry needling to the identified trigger point(s) per protocol. |
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| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |