Study to Evaluate the OrthoCor Active System for Pain Relief

December 8, 2022 updated by: Caerus Corporation

Prospective, Multi-Center, Randomized Study to Evaluate the OrthoCor Active System for Pain Relief

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education Foundation
    • New York
      • Smithtown, New York, United States, 11787
        • Orlin & Cohen Orthopedic Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Prescribed use of the OrthoCor Active System or Standard of Care (SOC) intervention
  3. Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

Exclusion Criteria:

  1. Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant
  2. Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain lead
  3. Who are or may be pregnant
  4. Have an open wound at the area of application
  5. Are not capable or fully aware to the sensation of heat
  6. Have poor circulation or heart disease
  7. Have diabetes
  8. Under the age of 18 or individuals with open bone growth plates
  9. Unable to provide consent or obtain consent from a LAR
  10. Unwilling or unable to use the OrthoCor Active System or Standard of Care (SOC) intervention
  11. Unwilling or unable to complete the daily pain assessment
  12. Enrolled in a study to evaluate an investigational drug
  13. Prisoner or under incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Experimental: OrthoCor Active System
Device: OrthoCor Active System
The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety EndPoint
Time Frame: after 2 weeks of use
Incidence of adverse events
after 2 weeks of use
Primary Efficacy EndPoint
Time Frame: after 2 weeks of use
comparison of Mankoski pain scale between OrthoCor and standard of care
after 2 weeks of use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caerus Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Anticipated)

January 30, 2023

Study Completion (Anticipated)

January 30, 2023

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PCM-OAS-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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