Signal Relief Patch in Musculoskeletal Pain
A Pilot Study of the Signal Relief Patch for the Treatment of Musculoskeletal Pain
1 other identifier
interventional
44
1 country
2
Brief Summary
assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2022
CompletedFirst Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2022
CompletedOctober 28, 2022
January 1, 2022
8 months
January 24, 2022
October 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
% 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 Outcomes (2)
Improvement in brief pain inventory score baseline to end 0-10 scale; 0 being no pain, 10 being worst pain
7 days
change in pain medication use baseline to end
7 days
Other Outcomes (1)
Exploratory
7 days
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Signal Relieflead
- Proxima CROcollaborator
- ITC Imaging, LLCcollaborator
Study Sites (2)
Valley of the Sun Institute for Pain Management
Scottsdale, Arizona, 85254, United States
Helios Health
Sedona, Arizona, 86336, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2022
First Posted
March 18, 2022
Study Start
January 21, 2022
Primary Completion
September 29, 2022
Study Completion
September 29, 2022
Last Updated
October 28, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share