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.

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.

Eligibility Criteria:
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