Virtual Reality as an Opioid Sparing Treatment for Chronic Pain

项目总结 慢性疼痛影响多达1.16亿美国人，是成年人寻求医疗服务的最常见原因之一 关心。传统上，疼痛的治疗和管理主要基于药物管理。 方法，通常涉及阿片类药物。阿片类药物通常用于治疗慢性疼痛，但这些药物 可能产生不一致的结果，具有显著的不良事件特征，并极大地增加患者的风险 开发阿片使用障碍(OUD)。慢性疼痛与阿片类药物依赖有关，20%-30%的患者 治疗慢性疼痛的处方阿片类药物滥用。尽管有大量的人接受处方 治疗疼痛，疼痛也是最未经治疗或治疗不足的医疗条件之一。双重奏 慢性疼痛和OUD的流行对低风险、综合性、非阿片类药物的需求提出了重大的未得到满足的需求 将上瘾风险降至最低的疼痛管理工具。 AppliedVR，Inc.(AppliedVR)计划利用我们在虚拟现实(VR)技术方面的现有成功来 解决未得到满足的需求，以更好的阿片类药物节省治疗替代治疗慢性疼痛 EaseVRx，我们基于软件的VR医疗设备。EaseVRx旨在为用户提供处方疼痛 管理工具，用于(A)管理与慢性疼痛相关的症状，(B)减少或消除 阿片类药物依赖的风险。EaseVRx基于认知行为疗法、疼痛心理学、 基于正念的减压、生物反馈和分散注意力的治疗策略 跨学科的疼痛康复计划。 这个直接到第二阶段的项目将通过评估推动EaseVRx的开发和商业化 EaseVRx在100名慢性下腰痛患者中的概念验证临床试验中的疗效。这场审判 将评估EaseVRx在减轻疼痛、减少阿片类/非阿片类药物治疗方面的有效性， 和提高生活质量。我们还将开发一种基于虚拟现实的测量工具，以便收集 VR耳机或应用程序内的患者报告结果，以便捕获结果数据和 有效测量EaseVRx疗效。此外，我们将为FDA II类准备提交前材料 软件即医疗设备许可。 这一第二阶段项目的成功完成将展示EaseVRx在治疗慢性疼痛方面的疗效 和减少阿片类药物的使用，并将导致提交前与FDA的对话，大大 推进发展规划。我们的最终目标是将EaseVRx带给医疗保健提供商和 使用这种基于VR的阿片类药物节制疼痛治疗来改善慢性阻塞性肺疾病患者的生活 疼痛。

PROJECT SUMMARY Chronic pain affects up to 116 million Americans and is one of the most common reasons adults seek medical care. Pain treatment and management is traditionally based primarily around pharmacological management methods, which typically involve opioids. Opioids are commonly prescribed for chronic pain, but these agents can yield inconsistent results, have significant adverse event profiles, and greatly increase the risk of the patient developing an Opioid Use Disorder (OUD). Chronic pain is linked to opioid dependence, and 20-30% of patients prescribed opioids for chronic pain misuse them. Despite the immense number of people receiving prescription therapeutics for pain, pain is also one of the most untreated or undertreated medical conditions. The dual epidemics of chronic pain and OUD pose a significant unmet need for low-risk, integrative, non-opioid pain management tools that minimize the risk of addiction. AppliedVR, Inc. (appliedVR) plans to leverage our existing success with virtual reality (VR) technology to address the unmet need for better opioid-sparing therapeutic alternatives to treat chronic pain with EaseVRx, our software-based VR medical device. EaseVRx is intended to offer users a prescription pain management tool that (a) manages the symptoms associated with chronic pain and (b) reduces or eliminates the risk of opioid dependence. EaseVRx is based on principles of cognitive behavioral therapy, pain psychology, mindfulness-based stress reduction, biofeedback, and distraction therapy strategies commonly used in interdisciplinary pain rehabilitation programs. This Direct-to-Phase II project will advance EaseVRx development and commercialization by evaluating EaseVRx efficacy in a proof-of-concept clinical trial in 100 patients with chronic low back pain. This trial will assess EaseVRx’s effectiveness in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving quality of life. We will also develop a VR-based surveying tool to allow for the collection of patient-reported outcomes inside the VR headset or application, in order to capture that outcome data and effectively measure EaseVRx efficacy. Additionally, we will prepare pre-submission materials for FDA Class II software-as-medical device clearance. Successful completion of this Phase II project will demonstrate EaseVRx’s efficacy in treating chronic pain and reducing opioid usage and will have resulted in pre-submission conversations with the FDA, significantly advancing the development program. Our ultimate goal is to bring EaseVRx to healthcare providers and use this VR-based opioid-sparing pain treatment to improve the lives of patients suffering from chronic pain.