Study to Evaluate the OrthoCor Active System for Pain Relief
Completed · Not applicable
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT05244187
- Run by
- Caerus Corporation
- People needed
- 120
- Starts
- 2022-11-07
- Expected to finish
- 2023-11-23
- Last updated by the study team
- 2025-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Andrews Research & Education Foundation — Gulf Breeze, Florida, United States
- GFC of Southeastern Michigan PC — Detroit, Michigan, United States
- Rothman Orthopedic Institute — Washington Township, New Jersey, United States
- Orlin & Cohen Orthopedic Group — Smithtown, New York, United States
- Spinal Pain and Rehabilitation Medicine — Yonkers, New York, United States
Full record on ClinicalTrials.gov
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