N/A
N=120
Study to Evaluate the OrthoCor Active System for Pain Relief
Pain
Bottom Line
View on ClinicalTrials.gov: NCT05244187 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Primary Safety EndPoint — 2; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OrthoCor Active System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Caerus Corporation
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety EndPoint |
2; 2 | — |
| PRIMARY Primary Efficacy EndPoint |
-1.8; -0.5 | — |
Summary
This is a prospective, multi-center, randomized, pivotal study to evaluate the OrthoCor Active System in individuals prescribed its use in comparison with the standard of care intervention for pain relief.
Eligibility Criteria
Inclusion Criteria
- Individuals presenting with pain in superficial soft tissue, such as ankle, back, knee, wrist, elbow, shoulder, foot, or neck pain, or minor muscular and joint aches and pains associated with over exertion, strains, sprains, or arthritis
- Prescribed use of the OrthoCor Active System or Standard of Care (SOC) intervention
- Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)
Exclusion Criteria
- Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant
- Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain lead
- Who are or may be pregnant
- Have an open wound at the area of application
- Are not capable or fully aware to the sensation of heat
- Have poor circulation or heart disease
- Have diabetes
- Under the age of 18 or individuals with open bone growth plates
- Unable to provide consent or obtain consent from a LAR
- Unwilling or unable to use the OrthoCor Active System or Standard of Care (SOC) intervention
- Unwilling or unable to complete the daily pain assessment
- Enrolled in a study to evaluate an investigational drug
- Prisoner or under incarceration
Data sourced from ClinicalTrials.gov (NCT05244187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.