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: 9897392
• 负责人: William TODD Maddox
• 金额: $ 103.96万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9897392
• 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 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

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，是成年人寻求医疗的最常见原因之一 关心。传统上，疼痛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慢性疼痛，但这些药物 可以产生不一致的结果，具有明显的不良事件概况，并大大增加患者的风险 发展阿片类药物使用障碍（OUD）。慢性疼痛与阿片类药物依赖性有关，患者中有20-30％ 开处方的慢性疼痛滥用它们。尽管收到处方的人数众多 治疗疼痛，疼痛也是最未经治疗或治疗的医疗状况之一。双重 慢性疼痛和OUD的流行病对低风险，综合性，非阿片类药物的需求很大 疼痛管理工具可最大程度地减少成瘾的风险。 Appliedvr，Inc。（AppliedVR）计划利用我们现有的虚拟现实（VR）技术成功 解决了对更好的阿片类药物治疗替代方案的未满足的需求，以治疗慢性疼痛 EASEVRX，我们的基于软件的VR医疗设备。 EASEVRX旨在为用户提供处方疼痛 管理工具（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，疼痛心理学的原则， 通常使用的基于正念的压力减轻，生物反馈和分心疗法策略 跨学科疼痛康复计划。 这个直接到相的II项目将通过评估来推动ISEASEVRX的开发和商业化 100例慢性腰痛患者的概念验证临床试验中的有效性。这个试验 将评估OESEVRX在减轻疼痛的有效性，减少Oioid/非阿片类药物治疗， 并改善生活质量。我们还将开发基于VR的测量工具，以收集 为了捕获该结果数据和 有效地测量easevrx的效果。此外，我们将为FDA II类准备提交材料 软件是医学设备清除率。 成功完成此II阶段项目将证明ISEASEVRX在治疗慢性疼痛方面的效率 并减少阿片类药物的使用情况，并将与FDA进行预审前对话 推进开发计划。我们的最终目标是将EASEVRX带到医疗保健提供者和 使用这种基于VR的阿片类药物止痛治疗来改善患有慢性病的患者的生活 疼痛。