Signal Relief Patch in Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288114
• Other study ID #: Signal -01-21
• Status: Completed
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: January 2022
• Source: Signal Relief
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Valley of the Sun Institute for Pain Management	Scottsdale	Arizona
United States	Helios Health	Sedona	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Signal Relief	ITC Imaging, LLC, Proxima CRO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory	assess biomarker SubstanceP in response to study therapy	7 days
Primary	% 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	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
Secondary	change in pain medication use baseline to end	subject-reported daily use of other medications intended for pain management using medication diary	7 days