Development of a Virtual Reality Graded Exposure Intervention for Low Back Pain

摘要 腰痛是看医生的第二大常见原因，也是腰部疼痛的主要原因。 巨大的费用主要是由7%-10%的慢性疼痛和残疾患者推动的。这个 慢性下腰痛(CLBP)的发病率正在稳步上升，并越来越依赖于药物和手术 干预并没有改善结果。与疼痛相关的恐惧已经成为最重要的 过渡到CLBP和维持CLBP的心理社会危险因素。高度恐惧的人会被困在 通过避免共同的体力活动，造成持续疼痛和残疾的循环。主要的干预措施 为了解决疼痛相关的恐惧和残疾，在体内进行分级暴露，这涉及到逐渐对抗 避免旨在纠正对痛苦和伤害的不准确预期的活动。然而，曝光的成功 干预工作受到资源成本高、获取/传播有限等问题的严重阻碍， 病人参与度低。 这项治疗发展计划汇集了来自医学、心理学和虚拟现实(VR)游戏的专家 利用创新的深度传感和运动跟踪功能，将分级曝光集成到游戏环境中 现有游戏技术的特点。这一新方法解决了当前暴露干预的局限性 通过降低治疗费用，促进获取和传播，并通过(1)利用 廉价的广泛可用的技术，(2)允许跨心理和行为对患者进行远程跟踪 结果，(3)促进在各种治疗环境中的干预，以及(4)增加患者参与度， 坚持，并通过游戏化激励。随着治疗的发展，我们的目标是进行多中心 临床试验，以检查基于家庭的虚拟现实游戏干预的有效性，以减少疼痛相关的恐惧和 CLBP高危人群中的残疾(“虚拟现实分级暴露”(VRGE)试验)。 作为目标1的一部分，专家指导委员会将规划一个有效的干预范例，并设计、制定 并测试VR游戏界面。目标2将确定在高度恐惧中进行干预的安全性和可行性 有慢性疼痛风险的参与者，包括一项基于实验室的试验，随后是一项基于家庭的试验。其他内容 感兴趣的结果将包括疼痛强度、疼痛干预、身体功能、心理社会结果以及 止痛药消费。来自试点测试的量化和焦点小组结果将为进一步完善 干预行动。作为目标3的一部分，指导委员会将为 预计VRGE试验，并为VRGE试验准备R01提交。 VR游戏干预的使用代表了一种解决与疼痛相关的恐惧和残疾的创新方法 在有慢性阻塞性肺疾病风险的个体中。这种治疗可以通过提供低水平的- 旨在促进获取、传播和患者参与的成本干预。最终，这种干预 预计将减少疼痛、残疾和适应不良应对疼痛，如过度服用止痛剂。

Abstract Low back pain is the second most common reason for visiting a physician and the leading cause of pain in the U.S., with enormous costs driven primarily by 7-10% of patients who develop chronic pain and disability. The incidence of chronic low back pain (CLBP) is steadily rising and greater reliance on pharmacological and surgical intervention has not improved outcomes. Pain-related fear has emerged as one of the most important psychosocial risk factors for transition to and maintenance of CLBP. High fear individuals become trapped in a cycle of continued pain and disability through avoidance of common physical activities. The leading intervention to address pain-related fear and disability is graded exposure in-vivo, which involves gradual confrontation of avoided activities aimed to correct inaccurate expectations of pain and harm. However, the success of exposure intervention has been significantly hampered by issues of high resource cost, limited accessibility/dissemination, and low patient engagement. This treatment development plan brings together experts from medicine, psychology, and virtual reality (VR) gaming to integrate graded exposure into a gaming environment utilizing the innovative depth-sensing and motion-tracking features of existing gaming technology. This novel approach addresses limitations of current exposure intervention by reducing treatment costs, promoting access and dissemination, and improving treatment gains by (1) utilizing inexpensive widely available technology, (2) allowing distal tracking of patients across psychological and behavioral outcomes, (3) facilitating intervention in a variety of treatment settings, and (4) increasing patient engagement, adherence, and motivation through gamification. Following treatment development, we aim to perform a multicenter clinical trial to examine the efficacy of a home-based VR gaming intervention to decrease pain-related fear and disability among individuals at risk for CLBP (the “Virtual Reality Graded Exposure” (VRGE) Trial). As part of Aim 1, the expert Steering Committee will plan an effective intervention paradigm, and design, develop and test the VR gaming interface. Aim 2 will establish the safety and feasibility of the intervention among high fear participants at risk for chronic pain, including a laboratory-based trial followed by a home-based trial. Additional outcomes of interest will include pain intensity, pain interference, physical function, psychosocial outcomes, and analgesic consumption. Quantitative and focus group findings from pilot testing will inform further refinement of the intervention. As part of Aim 3, the Steering Committee will write a manual of operations (MOOP) for the anticipated VRGE Trial and prepare an R01 submission for the VRGE Trial. The use of a VR gaming intervention represents an innovative approach to address pain-related fear and disability among individuals at risk for CLBP. The treatment can have a significant impact on public health by providing a low- cost intervention designed to promote access, dissemination, and patient engagement. Ultimately, this intervention is expected to reduce pain, disability, and maladaptive coping with pain such as excessive analgesic consumption.