Status:
COMPLETED
Study to Evaluate the OrthoCor Active System for Pain Relief
Lead Sponsor:
Caerus Corporation
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 re...
Detailed Description
According to the Centers for Disease Control and Prevention, 50 million adults in the United States have chronic daily pain, with 19.6 million adults experiencing high impact chronic pain that interfe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05244187
Start Date
November 7 2022
End Date
November 23 2023
Last Update
February 28 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States, 32561
2
GFC of Southeastern Michigan PC
Detroit, Michigan, United States, 48202
3
Rothman Orthopedic Institute
Washington Township, New Jersey, United States, 08080
4
Orlin & Cohen Orthopedic Group
Smithtown, New York, United States, 11787