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Signal Relief Pilot Study

Sponsor
Signal Relief (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05288114
Collaborator
Proxima CRO (Other), ITC Imaging, LLC (Other)
40
Enrollment
2
Locations
3.2
Anticipated Duration (Months)
20
Patients Per Site
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Signal Relief Patch
 Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain
Actual Study Start Date :
Jan 21, 2022
Anticipated Primary Completion Date :
Apr 29, 2022
Anticipated Study Completion Date :
Apr 29, 2022

Outcome Measures

Primary Outcome Measures

  1. % Reduction in Pain Baseline to End [7 days]

    using visual analogue pain scale ; 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 Outcome Measures

  1. Improvement in brief pain inventory score baseline to end [7 days]

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

  2. 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 Outcome Measures

  1. Exploratory [7 days]

    assess biomarker SubstanceP in response to study therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Valley of the Sun Institute for Pain Management Scottsdale Arizona United States 85254
2 Helios Health Sedona Arizona United States 86336

Sponsors and Collaborators

  • Signal Relief
  • Proxima CRO
  • ITC Imaging, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Signal Relief
ClinicalTrials.gov Identifier:
NCT05288114
Other Study ID Numbers:
  • Signal -01-21
First Posted:
Mar 18, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Musculoskeletal Pain

Study Results

No Results Posted as of Mar 18, 2022