Signal Relief Patch in Musculoskeletal Pain

NCT ID: NCT05288114

Last Updated: 2022-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2022-09-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Musculoskeletal Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Signal Relief Patch

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Proxima CRO

INDUSTRY

Sponsor Role collaborator

ITC Imaging, LLC

UNKNOWN

Sponsor Role collaborator

Signal Relief

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Valley of the Sun Institute for Pain Management

Scottsdale, Arizona, United States

Site Status

Helios Health

Sedona, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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Signal -01-21

Identifier Type: -

Identifier Source: org_study_id

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