Study to Evaluate the OrthoCor Active System for Pain Relief

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: Completed
• Conditions: Pain
• Intervention / Treatment: Device: OrthoCor Active System

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 interferes with daily life or work activities. Clinical best practices may recommend a collaborative, multimodal, multidisciplinary, patient-centered approach to treatment for various acute and chronic pain conditions to achieve optimal patient outcomes. For improved functionality, activities of daily living, and quality of life, clinicians are encouraged to consider and prioritize, when clinically indicated, nonpharmacologic approaches to pain management.

An alternative treatment option can be the use of restorative therapies. Restorative therapies play a significant role in acute and chronic pain management, and positive clinical outcomes are more likely if restorative therapy is part of a multidisciplinary treatment plan following a comprehensive assessment.

The OrthoCor Active System uses specialized Pulsed Electromagnetic Field (PEMF) technology to relieve pain and reduce edema through safe, clinically proven therapy. PEMF is a low-level, time-varying electromagnetic field that penetrates superficial soft tissue, helping to accelerate the body's natural anti-inflammatory and recovery responses. Inside every OrthoCor Active System is proprietary electronic circuitry that delivers PEMF to the source of injuries. PEMF has been shown to stimulate reaction pathways that result in pain and inflammation reduction. OrthoCor's patented PEMF accelerates the binding of calcium (Ca2+) to calmodulin (CaM), the process responsible for the body's natural, antiinflammatory nitric oxide (NO) cascade. NO is a key element in the body's natural healing process. It is also a vasodilator, increasing blood and lymphatic flow. Additionally, NO down-regulates interleukin-1 beta (IL1β) and inducible nitric oxide synthase (iNOS), which leads to reduced cyclooxygenase-2 (COX-2) and prostaglandins - molecules responsible for causing inflammation and pain. Unlike other systemic COX-2 inhibitors such as nonsteroidal anti-inflammatory drugs (NSAIDs), OrthoCor's targeted PEMF signals stimulate localized reaction pathways, thereby reducing pain and inflammation without the risks and side effects associated with NSAIDs.

In previous clinical studies, OrthoCor Active System was clinically proven to reduce pain, swelling and provide lasting relief without the use of pain medications or invasive procedures. OrthoCor Medical Inc. conducted a prospective, double blind, placebo controlled, randomized pilot study (2014-2016), enrolling 80 patients with Kellgren-Lawrence knee arthritis who used the OrthoCor knee system, which showed a significant 60% reduction in the mean pain score within the first 3 days of use compared with the sham group 2. A preliminary study conducted by OrthoCor Medical Inc. in 33 patients suffering from knee osteoarthritis utilizing the OrthCor knee system, showed reduced pain and stiffness after 15 days of treatment with a 43% reduction in pain score and a 79% improvement in activity limitations, symptoms, emotions, and overall quality of life.

The OrthoCor Active System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of pain in superficial soft tissue, such as in the ankle, back, knee, wrist, elbow, shoulder, foot, or neck. The OrthoCor Active System delivers the pulsed RF signal of 6.5+0.5 Ws/cm3 to the tissue target via the inductive coupling with an applicator coil. The system also uses disposable, single-use, air activated OrthoPods that provide heat for the temporary relief of minor muscular & joint aches & pains associated with overexertion, strains, sprains, and arthritis.

The objective of this study is to evaluate the OrthoCor Active System in individuals presenting with post-operative pain and edema in superficial soft tissue. The OrthoCor Active System will be compared to the SOC intervention.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Research & Education Foundation
  • Michigan
    • Detroit, Michigan, United States, 48202
      • GFC of Southeastern Michigan PC
  • New Jersey
    • Washington Township, New Jersey, United States, 08080
      • Rothman Orthopedic Institute
  • New York
    • Smithtown, New York, United States, 11787
      • Orlin & Cohen Orthopedic Group
    • Yonkers, New York, United States, 10701
      • Spinal Pain and Rehabilitation Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OrthoCor Active System; OrthoCor Active System used for pain relief	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.
No Intervention: Standard of care; standard of care: over-the-counter pain medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety EndPoint	Number of participants with adverse events	after 2 weeks of use
Primary Efficacy EndPoint	Change from baseline of Mankoski pain scale between OrthoCor and standard of care. The Mankoski pain scale ranges from 0 representing no pain to 10 representing pain causing unconsciousness.	at baseline compared to during 2 weeks of use

Collaborators and Investigators

• Sponsor: Caerus Corporation
• Investigators: Principal Investigator: Joshua G Hackel, MD, Andrews Research and Education Foundation

Publications and helpful links

General Publications

• Hackel JG, Paci JM, Gupta S, Maravelas DA, North TJ, Paunescu A. Evaluating Noninvasive Pulsed Electromagnetic Field Therapy for Joint and Soft Tissue Pain Management: A Prospective, Multi-center, Randomized Clinical Trial. Pain Ther. 2025 Feb 10. doi: 10.1007/s40122-025-00711-z. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): November 23, 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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PCM-OAS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No