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Signal Relief Patch in Musculoskeletal Pain

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Signal Relief Patch
Sponsored by
Signal Relief
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Valley of the Sun Institute for Pain Management
  • Helios Health

Outcomes

Primary Outcome Measures

% 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

Secondary Outcome Measures

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
change in pain medication use baseline to end
subject-reported daily use of other medications intended for pain management using medication diary

Full Information

First Posted
January 24, 2022
Last Updated
October 26, 2022
Sponsor
Signal Relief
Collaborators
Proxima CRO, ITC Imaging, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05288114
Brief Title
Signal Relief Patch in Musculoskeletal Pain
Official Title
A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Signal Relief
Collaborators
Proxima CRO, ITC Imaging, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Signal Relief Patch
Intervention Description
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 Outcome Measure Information:
Title
% change in Pain Baseline to End
Description
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 Outcome Measure Information:
Title
Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain
Description
proportional change in subject-reported scores on the Brief Pain Inventory Form
Time Frame
7 days
Title
change in pain medication use baseline to end
Description
subject-reported daily use of other medications intended for pain management using medication diary
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Exploratory
Description
assess biomarker SubstanceP in response to study therapy
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Valley of the Sun Institute for Pain Management
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Helios Health
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Signal Relief Patch in Musculoskeletal Pain

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