Signal Relief Patch in Musculoskeletal Pain

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

assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Device: Signal Relief Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Valley of the Sun Institute for Pain Management
    • Sedona, Arizona, United States, 86336
      • Helios Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory	assess biomarker SubstanceP in response to study therapy	7 days

Collaborators and Investigators

• Sponsor: Signal Relief
• Collaborators: Proxima CRO; ITC Imaging, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: Signal -01-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No