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| Name | Class |
|---|---|
| Proxima CRO | INDUSTRY |
| ITC Imaging, LLC | UNKNOWN |
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assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain
The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries. Nano-capacitors utilized within the Signal Relief Patch were originally developed to replace military antenna systems with no additional power supply. Since development, it was incidentally found that these nano-capacitors may help control pain by working with the body's electrical system. Although the details of how these nano-capacitors facilitate the alleviation of pain are still under investigation, the possibility of reducing pain through a non-invasive, nonpharmacological method is extremely appealing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signal Relief Patch | Device | Eligible subjects will be provided a Signal Relief patch, the instructions for use, and patch placement materials (adhesive, athletic tape, or wrap as applicable for the location of the pain). Subjects will be instructed to use the patch daily for seven days. The patch must be worn constantly except when showing or swimming. |
| Measure | Description | Time Frame |
|---|---|---|
| % change in Pain Baseline to End | using visual analogue, proportion of subjects achieving at least a 30% reduction in reported pain on the visual analog scale score from baseline to the end of treatment.measurement and pain medication diary | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain | proportional change in subject-reported scores on the Brief Pain Inventory Form | 7 days |
| change in pain medication use baseline to end |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory | assess biomarker SubstanceP in response to study therapy | 7 days |
Inclusion Criteria:
Exclusion Criteria:
- 1. Receiving other investigational agents or on another clinical trial. 2. In emergent need for pain management. 3. Acute injury requiring rapid intervention or treatment. 4. The subject is using prescription medications (e.g., celecoxib, codeine, oxycodone, prednisone, etc.) for pain management regularly or PRN.
5. The subject is currently undergoing or planning to begin physical therapy. 6. The subject is planning to begin a new exercise routine. 7. Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device 8. Known to be pregnant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley of the Sun Institute for Pain Management | Scottsdale | Arizona | 85254 | United States | ||
| Helios Health |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 22, 2024 | May 16, 2024 | 3 | ||
| May 21, 2025 |
| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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subject-reported daily use of other medications intended for pain management using medication diary
| 7 days |
| Sedona |
| Arizona |
| 86336 |
| United States |
| Jun 9, 2025 |
| 4 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |