Musculoskeletal Pain
Conditions
Brief summary
assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain
Detailed description
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.
Interventions
DEVICESignal Relief Patch
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.
Sponsors
Proxima CRO
ITC Imaging, LLC
Signal Relief
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subject aged ≥ 18 years. 2. Currently seeking treatment for chronic musculoskeletal pain management. 3. Visual analog scale score \> 4 at baseline. 4. Willing to refrain from the use of prescription pain medications during study participation. 5. Able and willing to provide informed consent.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % change in Pain Baseline to End | 7 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain | 7 days | proportional change in subject-reported scores on the Brief Pain Inventory Form |
| change in pain medication use baseline to end | 7 days | subject-reported daily use of other medications intended for pain management using medication diary |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory | 7 days | assess biomarker SubstanceP in response to study therapy |
Countries
United States
Outcome results
None listed