A Telemedicine Home-Based Study of Healables Wearable Electroceutical & Sports Sleeve Designed for Pain Relief & Improved Function in Mild to Moderate Knee Osteoarthritis Including in Persons With Chronic Illness Following Sports Injury

INTRODUCTION Definitions: an electroceutical, compared to a pharmaceutical, is a device that provides treatment by delivering potentially therapeutic electrical pulses; a microcurrent electroceutical delivers electrical pulses in the micro-ampere range and is distinguished from devices that deliver millicurrent which are electrical pulses in the milliampere range, 1000-fold greater than the micro ampere range.

Electrical microcurrent therapy represents a significant improvement in rapid pain control and acceleration of healing since it not only avoids the side effects of drugs including opioids and NSAIDs, but is also a superior electroceutical modality since it uses 1000-fold less electric current than that of Transcutaneous Electrical Nerve Stimulation (TENS), which requires application of current in the millicurrent range and can itself be painful and damaging to nerve tissues.

Electrotherapy, especially microcurrent electrical therapy, has been used to treat a variety of clinical conditions and is routinely used at pain clinics in the USA, most notable among them, the Cleveland Clinic, consistently rated among the top 3 medical centers in the USA. Microcurrent electro-therapy may be the best treatment for many pain-related disorders, since it not only provides fast relief of symptoms and promotes quick healing but also it has significantly fewer adverse side effects than many analgesic drugs. Indeed, this Cleveland Clinic website lists multiple diseases and disorders amenable to microcurrent therapy to ameliorate pain as do numerous published studies. Unfortunately, such microcurrent therapy is traditionally administered using a large desktop instrument through electrodes positioned by a health practitioner so that current can flow between the electrodes through the affected area of pain. While many practitioners in the USA are competent to administer such microcurrent therapy in both small and large clinical settings, treatment often requires significant travel by the patient who may be in considerable pain. Hence, patients frequently forego microcurrent therapy to avoid multiple trips to the health care provider at a clinic which may be quite distant.

Microcurrent Electroceutical: Healables Ltd. has determined that microcurrent therapy can be designed as a wearable medical device for use at home, at work or when travelling. This functional innovation provides a solution to provide widespread availability of microcurrent therapy. Healables has miniaturized a device that can deliver microcurrent electrotherapy and has devised a way to dock it to wearable e-textiles such sleeves, socks or body shirts with built in electrode paths to deliver microcurrent signals to the affected areas. Powered by an smart phone App (provided), the subject can wear the Healables device at home, work or in transit to provide timely and, if warranted, frequent microcurrent therapy at his/her leisure. Moreover, the App allows the subject to remotely communicate with health providers by digital health telecommunication to report and document daily progress.

The purpose of this clinical trial at the Edith Wolfson Medical Center (WMC) is to demonstrate the safety, tolerability and usability of a Healables electroceutical device in subjects with mild to moderate osteoarthritis pain and/or dysfunction to promote healing of chronic mild to moderate knee osteoarthritis as shown by relief of pain and decreased disability.