Virtual Reality as a Opioid Sparing Intervention for Acute Postoperative Pain Management

虚拟现实作为阿片类药物节省干预措施用于急性术后疼痛管理

• 批准号: 10025175
• 负责人: Sabry Ayad
• 金额: $ 76.47万
• 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/10025175
• 关键词: Acute; Acute Pain; Acute pain management; Address; American; Caregivers; Centers for Disease Control and Prevention (U.S.); Clinic; Clinical Protocols; Clinical Research; Clinical Trials; Complement; Computer software; Conduct Clinical Trials; Data; Data Collection; Dependence; Development; Devices; Feedback; Foundations; Future; Health system; Healthcare; Hospitalization; Hospitals; Incidence; Informed Consent; Infrastructure; Intervention; Label; Language; Lead; Libraries; Measurement; Medical Device; Methods; Modeling; Operative Surgical Procedures; Opioid; Orthopedics; Outcome Study; Pain management; Patients; Perioperative; Phase; Postoperative Pain; Postoperative Period; Procedures; Process; Production; Protocols documentation; Reporting; Risk; Safety; Substance abuse problem; System; Techniques; Technology; Therapeutic; United States; addiction; base; cloud based; cognitive modulation of pain; commercialization; distraction; hip replacement arthroplasty; improved; improved functioning; knee replacement arthroplasty; meetings; non-opioid analgesic; opioid epidemic; opioid sparing; opioid therapy; opioid use disorder; opioid user; pain reduction; pain relief; pain score; prescription opioid; prevent; primary outcome; standard of care; success; surgery outcome; tool; virtual reality; virtual reality headset; virtual reality system

ABSTRACT Millions of Americans undergo surgery each year with fewer than half of patients reporting adequate postoperative pain relief and approximately 75% reporting moderate to severe postoperative pain. Gaps in postoperative pain management that lead to the unnecessary introduction and over-prescription of opioids continue to exacerbate the opioid crisis. Data from the US Center for Disease Control (CDC) revealed that even a single day of opioid therapy can predict up to a 6% increase in the risk of the patient developing a dependency within a year. appliedVR plans to combine its existing success with Virtual Reality (VR)-based technology to provide acute perioperative pain management through a new software-based VR medical device, RelieVRx™. In Phase I, we developed therapeutic virtual reality content focused on strategies for substance abuse. RelieVRx is intended to prevent the onset of Opioid Use Disorder (OUD) via enhanced opioid sparing techniques. Initial clinical studies have shown our content has reduced patient’s pain scores not only while the patient is actively utilizing the device, but also following the treatment. In Phase II, we will improve the functionality of the device, conduct two clinical trials to validate the use of RelieVRx™ for pain management after total hip or knee arthroplasty, and prepare a report of our findings to the FDA for class 2 SaMD clearance. In Aim 1, we will optimize the backend infrastructure (e.g., storage, access to data, delivery of content) of the RelieVRx™ platform to improve content storage, distribution and FDA-compliant data collection. In Aims 2 and 3, we will conduct two 100 patient trials to assess the efficacy of RelieVRx for acute pain management after total hip or knee arthroplasty in partnership with the Cleveland Clinic and Geisinger Health System, respectively. Lastly, in Aim 4, we will prepare the materials/reports garnered through our studies for a de novo submission to the FDA for class 2 SaMD clearance. Over $13 billion in annual healthcare dollars go to treating addiction associated with postoperative pain management. Annually an estimated 2.6 million people undergoing surgery will become persistent opioid users. As a non-opioid alternative intended to reduce postoperative pain and reduce the need for and utilization of opioids in the postoperative setting, RelieVRx stands to change the course of the opioid epidemic and dramatically improve the state of surgical outcomes for millions of patients, doctors, and caregivers.

抽象的 每年有数百万美国人接受手术，但只有不到一半的患者报告足够 术后疼痛缓解，约 75% 的患者报告中度至重度术后疼痛。差距 术后疼痛管理导致不必要的阿片类药物的引入和过度处方 继续加剧阿片类药物危机。美国疾病控制中心（CDC）的数据显示， 即使单日阿片类药物治疗也可预测患者患上阿片类药物的风险增加高达 6% 一年内依赖。 AppliedVR 计划将其现有的成功与基于虚拟现实 (VR) 的技术相结合 技术通过基于软件的新 VR 医疗提供急性围手术期疼痛管理 设备，RelieVRx™。在第一阶段，我们开发了治疗性虚拟现实内容，重点关注以下策略： 药物滥用。 RelieVRx 旨在通过增强功能来预防阿片类药物使用障碍 (OUD) 的发作 阿片类药物节约技术。初步临床研究表明，我们的内容并未降低患者的疼痛评分 仅在患者积极使用该设备时以及在接受治疗时进行。在第二阶段，我们将 改进设备的功能，进行两项临床试验来验证 RelieVRx™ 治疗疼痛的用途 全髋关节或膝关节置换术后的管理，并向 FDA 准备一份 2 类研究结果报告 SaMD 许可。在目标 1 中，我们将优化后端基础设施（例如存储、数据访问、交付 RelieVRx™ 平台的内容），以改进内容存储、分发和符合 FDA 标准的数据 收藏。在目标 2 和 3 中，我们将进行两项 100 名患者试验，以评估 RelieVRx 对急性 与克利夫兰诊所和 Geisinger 合作进行全髋关节或膝关节置换术后的疼痛管理 分别是卫生系统。最后，在目标 4 中，我们将准备通过我们的研究收集的材料/报告 向 FDA 提交 2 类 SaMD 许可的从头提交研究。每年医疗保健费用超过 130 亿美元 美元用于治疗与术后疼痛管理相关的成瘾。每年估计 2.6 数百万接受手术的人将成为持续的阿片类药物使用者。作为非阿片类药物替代品，旨在 减少术后疼痛并减少术后对阿片类药物的需求和使用， RelieVRx 将改变阿片类药物流行的进程并显着改善外科手术的状况 数以百万计的患者、医生和护理人员的结果。