Signal Relief Patch in Musculoskeletal Pain

Study Overview
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Brief Summary
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assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain

Detailed Description
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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.

Official Title
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A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Device: Signal Relief Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject aged ≥ 18 years. Currently seeking treatment for chronic musculoskeletal pain management. Visual analog scale score > 4 at baseline. Willing to refrain from the use of prescription pain medications during study participation. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Signal 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | subject-reported daily use of other medications intended for pain management using medication diary | 7 days |