Using Augmented Reality illusion therapy to develop a non-opioid chronic pain digital treatment

PROJECT SUMMARY/ABSTRACT (30 LINES OF TEXT) Arthritis is the leading cause of disability among adults, affecting 54 million Americans today and estimated to grow to 78 million arthritis sufferers by 2040. Arthritis is the most common chronic condition among chronic users of opioids in the US, accounting for the largest portion of the $200 billion cost to society of opioid use disorder. Of Americans with arthritis, 25 million live with severe joint pain. Current approaches to address arthritis pain, such as opioids, surgery, and physical therapies are invasive, expensive, and come with associated risks and unwanted adverse side effects. Thus, there is an unmet need to develop an alternative therapy that can relieve joint pain for patients with similar (or better) efficacy that is digital, drug-free, more permanent, low risk, low cost, and accessible. VRx Medical (VRx) plans to leverage its existing success with a Virtual Reality (VR) experience addressing Phantom Limb Pain and complete development of a new smartphone-based Augmented Reality (AR) medical device, Nottingham. Nottingham is a smartphone app that uses Augmented Reality (AR) to ameliorate arthritis pain in the hands, feet, and knees. Nottingham will enable customers with joint pain to self- manage their own condition at a lower cost and risk than other remedies available, including opioids and other similar addictive pain medications. A component of arthritic pain has brain-based origins; therefore, using AR to change what the brain “sees” has the same cortical reorganization benefits of Mirror Therapy (MT) and illusions that reduce pain in complex regional pain syndrome type 1 (CRPS1) patients. Also, like Mirror Therapy, Nottingham has promising potential to impact the cortical plasticity of the brain with effects that lead to long- lasting pain relief. This Phase I project will optimize the Nottingham AR therapy development and commercialization by evaluating Nottingham efficacy in a proof-of-concept feasibility study with 36 diagnosed osteoarthritis sufferers. The study is designed to further investigate the underlying mechanisms and validate the beneficial effects for pain and opioid use. Efficacy data and pre/post therapy fMRI scans will be compared for and analyzed. Completion of Phase I will enable VRx to perform a larger Phase II clinical study to provide an alternative pain management therapy to opioids. Our ultimate goal is to bring Nottingham to end-users, payers, employers, and health plans and use this novel, AR-based, opioid-avoiding pain treatment to improve the lives of arthritis patients suffering from joint pain.