Study to Evaluate the OrthoCor Active System for Pain Relief

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05244187
• Other study ID #: PCM-OAS-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2022
• Source: Caerus Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Andrews Research & Education Foundation	Gulf Breeze	Florida
United States	Orlin & Cohen Orthopedic Group	Smithtown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Caerus Corporation

Country where clinical trial is conducted

United States, 

Outcome

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