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

项目摘要 关节炎是成年人残疾的主要原因，今天影响5400万美国人，估计 到2040年将增加到7800万关节炎患者。关节炎是慢性使用者中最常见的慢性疾病 阿片类药物在美国的使用，占阿片类药物使用障碍社会2000亿美元成本的最大部分。 在患有关节炎的美国人中，有2500万人患有严重的关节疼痛。目前解决关节炎疼痛的方法， 例如阿片类药物、手术和物理治疗是侵入性的、昂贵的，并且伴随着相关的风险， 不良副作用因此，存在未满足的需求，即开发一种可以缓解疼痛的替代疗法。 关节疼痛的患者具有类似（或更好）的疗效，即数字化，无药物，更持久，低风险，低成本， 并且容易接近。VRx Medical（VRx）开发了一款智能手机应用程序“诺丁汉”， 现实（AR），以减轻关节炎疼痛的手，脚，和膝盖。诺丁汉将为客户提供 关节疼痛自我管理自己的条件，以较低的成本和风险比其他补救措施，包括 阿片类药物和其他类似的成瘾性止痛药。关节炎疼痛的一个组成部分有脑基础的起源; 因此，使用AR来改变大脑“看到”的东西具有与Mirror相同的皮层重组益处。 治疗（MT）和幻觉，减少疼痛的复杂区域疼痛综合征1型（CRPS 1）患者。还有， 像镜像疗法一样，诺丁汉有潜力影响大脑皮层的可塑性， 可以长期缓解疼痛该I期项目将优化诺丁汉AR疗法的开发 通过在一项概念验证可行性研究中评估诺丁汉的疗效， 确诊的骨关节炎患者。该研究旨在进一步研究潜在的机制， 验证与安慰剂版本的应用程序相比的有益效果。参与者将收到 AR或安慰剂治疗三个月。将提供疗效数据和治疗前/后fMRI扫描 比较各组。I期的完成将使VRx能够进行更大规模的II期临床研究， 提供阿片类药物的替代疼痛管理疗法。我们的最终目标是终结诺丁汉- 用户，付款人，雇主和健康计划，并使用这种新颖的，基于AR的，避免阿片类药物的疼痛治疗， 改善关节炎患者因关节疼痛而痛苦的生活。

PROJECT SUMMARY 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) has developed “Nottingham”, 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 20 diagnosed osteoarthritis sufferers. The study is designed to further investigate the underlying mechanisms and validate the beneficial effects as compared to a placebo version of the app. Participants will receive either the AR or placebo therapy treatment for three months. Efficacy data and pre/post therapy fMRI scans will be compared for each group. 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.