Signal Relief Patch in Musculoskeletal Pain

Signal Relief44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Musculoskeletal Pain

Interventions

Signal Relief PatchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Valley of the Sun Institute for Pain Management

Scottsdale, Arizona, United States

Helios Health

Sedona, Arizona, United States

Outcomes

Primary Outcomes

% 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

Time frame: 7 days

Secondary Outcomes

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

Time frame: 7 days

change in pain medication use baseline to end

subject-reported daily use of other medications intended for pain management using medication diary

Time frame: 7 days

Data from ClinicalTrials.gov

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