Virtual Reality as an Opioid Sparing Treatment for Chronic Pain

虚拟现实作为慢性疼痛的阿片类药物节省治疗方法

• 批准号: 10025584
• 负责人: William TODD Maddox
• 金额: $ 43.33万
• 依托单位: APPLIEDVR, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10025584
• 关键词: Address; Adult; Advanced Development; Adverse event; Affect; American; Biofeedback; Cardiovascular Diseases; Caring; Chronic low back pain; Clinic; Clinical; Clinical Pathways; Clinical Trials; Cognitive Therapy; Collaborations; Collection; Computer software; Coping Skills; Data; Development; Devices; Diabetes Mellitus; Dose; Effectiveness; Enrollment; Epidemic; Feedback; Future; Goals; Health Insurance Portability and Accountability Act; Health Personnel; Home environment; Institutes; Label; Language; Link; Malignant Neoplasms; Measures; Medical; Medical Device; Medication Management; Methods; Modality; Musculoskeletal; Opiate Addiction; Opioid; Outcome; Outcome Assessment; Outcomes Research; Pain; Pain management; Participant; Patient Outcomes Assessments; Patients; Pharmacotherapy; Phase; Physicians; Prescription opioid overdose; Program Development; Provider; Psychology; Quality of life; Questionnaires; Randomized; Regulatory Pathway; Reporting; Research; Risk; SF-12; Safety; Secure; Self Administration; Self Efficacy; Small Business Innovation Research Grant; Surveys; Technology; Therapeutic; Treatment outcome; Validation; Visual; addiction; analog; arm; associated symptom; base; chronic pain; chronic pain management; chronic pain patient; commercialization; compliance behavior; design; distraction; electronic data capture system; experience; health economics; improved; meetings; milligram; mindfulness-based stress reduction; morphine equivalent; non-opioid analgesic; opioid sparing; opioid use; opioid use disorder; pain catastrophizing; pain rehabilitation; prescription opioid; prescription opioid misuse; programs; research study; risk minimization; success; symptom management; tool; virtual reality; virtual reality headset

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.

项目摘要 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。 在乎疼痛治疗和管理传统上主要基于药物管理 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，并大大增加患者的风险 阿片类药物使用障碍（OUD）慢性疼痛与阿片类药物依赖有关，20-30%的患者 用于治疗慢性疼痛的阿片类药物滥用。尽管有大量的人接受处方药 虽然疼痛是一种常见的治疗方法，但疼痛也是最未经治疗或治疗不足的医学病症之一。双 慢性疼痛和OUD的流行造成了对低风险、综合性、非阿片类药物的显著未满足的需求， 疼痛管理工具，最大限度地减少成瘾的风险。 VR技术（appliedVR）计划利用我们在虚拟现实（VR）技术方面的现有成功， 解决对更好的阿片类药物保留治疗替代品的未满足需求，以治疗慢性疼痛， 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，其（a）管理与慢性疼痛相关的症状，和（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，生物反馈和分心治疗策略通常用于 跨学科疼痛康复计划。 这个直接进入第二阶段的项目将通过评估来推进EaseVRx的开发和商业化 EaseVRx在100例慢性腰痛患者中的概念验证临床试验中的疗效。本试验 将评估EaseVRx在减轻疼痛，减少阿片类/非阿片类药物治疗， 和提高生活质量。我们亦会开发一个以虚拟现实为基础的测量工具， 在VR头显或应用程序中记录患者报告的结果，以便捕获结果数据， 有效测量EaseVRx功效。此外，我们将准备FDA II类的预提交材料 软件即医疗器械许可。 这个二期项目的成功完成将证明EaseVRx在治疗慢性疼痛方面的疗效 减少阿片类药物的使用，并将导致与FDA的提交前对话， 推进发展计划。我们的最终目标是将EaseVRx带给医疗保健提供商， 使用这种基于VR的阿片类药物保留疼痛治疗来改善慢性疼痛患者的生活， 痛苦