Skip to main content
OpenTrials
Completed

NCT Number: NCT05288114

Signal Relief Patch in Musculoskeletal Pain

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley of the Sun Institute for Pain Management, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. % change in Pain Baseline to End

    Time frame: 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 outcomes

  1. Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain

    Time frame: 7 days

    proportional change in subject-reported scores on the Brief Pain Inventory Form

  2. change in pain medication use baseline to end

    Time frame: 7 days

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

Other outcomes

  1. Exploratory

    Time frame: 7 days

    assess biomarker SubstanceP in response to study therapy

Sponsors and collaborators

Lead sponsor

Signal Relief

Industry

Collaborators

  • ITC Imaging, LLC
  • Proxima CRO

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.