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

项目总结 关节炎是成年人致残的主要原因，目前影响着5400万美国人，据估计 到2040年，关节炎患者将增长到7800万。关节炎是慢性使用者中最常见的慢性疾病 在阿片类药物使用障碍给社会造成的2000亿美元成本中，占最大部分。 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， 如阿片类药物、手术和物理疗法是侵入性的、昂贵的，并伴随着相关的风险和 不想要的副作用。因此，有一种尚未得到满足的需求，即开发一种替代疗法，可以缓解 关节疼痛的患者具有类似(或更好)的疗效，即数字化、免药物、更持久、低风险、低成本、 而且容易接近。VRX医疗公司(VRX Medical)开发了一款名为“诺丁汉”(Nottingham)的智能手机应用程序，它使用增强版 现实(AR)，以改善手、脚和膝盖的关节炎疼痛。诺丁汉将为客户提供 关节疼痛，以比其他可用的治疗方法更低的成本和风险自我管理自己的情况，包括 阿片类药物和其他类似的上瘾止痛药。关节炎疼痛的一种成分源于大脑； 因此，使用增强现实技术来改变大脑“看到”的东西具有与镜像仪相同的皮质重组益处 治疗(MT)和减少复杂区域疼痛综合征1型(CRPS1)患者疼痛的错觉。另外， 像镜子疗法一样，诺丁汉有希望通过效应影响大脑皮质的可塑性 这会带来持久的止痛效果。这个第一阶段的项目将优化诺丁汉AR治疗的开发 和商业化，通过评估诺丁汉的有效性在概念验证可行性研究中与20 诊断为骨关节炎患者。这项研究的目的是进一步调查潜在的机制和 与安慰剂版本的应用程序相比，验证其有益效果。参赛者将获得 AR或安慰剂治疗三个月。疗效数据和治疗前后的fMRI扫描将 对每一组进行比较。第一阶段的完成将使VRX能够进行更大的第二阶段临床研究 提供一种替代阿片类药物的疼痛管理疗法。我们的最终目标是结束诺丁汉- 用户、付款人、雇主和健康计划，并使用这种基于AR的新型阿片类药物避免疼痛治疗 改善患有关节痛的关节炎患者的生活。

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.