Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.
Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.
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DOI：
10.2196/25291
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发表时间：
2021-01-19
影响因子：
1.7
通讯作者：
Birckhead BJ
中科院分区：
文献类型：
--
作者：
Garcia LM;Darnall BD;Krishnamurthy P;Mackey IG;Sackman J;Louis RG;Maddox T;Birckhead BJ
慢性疼痛是最常见且令人衰弱的健康状况之一。慢性腰痛的治疗通常侧重于生物医学治疗方法。尽管存在心理社会治疗，但多种障碍阻碍了广泛的治疗。对于慢性疼痛的综合、易于获得的非阿片类药物解决方案的需求尚未得到满足。虚拟现实 (VR) 是一种沉浸式技术，可实现行为疼痛治疗的创新。基于行为技能的 VR 可有效促进疼痛管理并减少与疼痛相关的担忧。需要对这些新兴方法进行持续研究。在这项随机对照试验中，我们试图测试基于自我管理行为技能的 VR 项目作为非药物家庭疼痛管理治疗慢性腰痛 (cLBP) 患者的功效。我们将 180 名 cLBP 患者随机分配到 2 个 VR 项目中的 1 个：(1) EaseVRx（为期 8 周的基于技能的 VR 项目）；或（2）假VR（对照条件）。所有参与者都将收到 VR 耳机，以尽量减少与该技术新颖性相关的任何偏见。 Sham VR 小组在类似 3D 影院的环境中拥有 2D 中性内容。我们的主要结果是平均疼痛强度以及疼痛对活动、压力、情绪和睡眠的干扰。我们的次要结局包括患者报告的身体功能、睡眠障碍、疼痛自我效能、疼痛灾难化、疼痛接受度、健康利用、药物使用和用户满意度。我们假设与控制条件相比，基于技能的 VR 程序在所有这些措施中都具有优越性。对治疗分配不知情的团队统计学家将使用适合数据纵向性质的方法评估治疗后长达 6 个月的结果。该研究于2020年7月2日获得西方机构审查委员会批准。方案（NCT04415177）于2020年5月27日注册。该研究的招募于2020年7月完成，数据收集将持续到2021年3月。总共招募了186名参与者。这项研究将产生多份手稿。主要手稿将于 2020 年冬季提交出版。在 VR 中有效提供行为治疗可以克服护理障碍，并为慢性疼痛的社会负担提供可扩展的解决方案。我们的研究可以帮助塑造这些创新方法的未来研究和开发。 ClinicalTrials.gov NCT04415177； https://clinicaltrials.gov/ct2/show/NCT04415177 RR1-10.2196/25291
Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 RR1-10.2196/25291
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DOI：
10.1111/j.1532-5415.2005.53268.x
发表时间：
2005-05-01
影响因子：
6.3
作者：
Austrian, JS;Kerns, RD;Reid, MC
通讯作者：
Reid, MC
影响因子：
3.1
作者：
Darnall, Beth D.;Ziadni, Maisa S.;Wheeler, Amanda
通讯作者：
Wheeler, Amanda
影响因子：
3.6
作者：
Gold, Jeffrey I.;Mahrer, Nicole E.
通讯作者：
Mahrer, Nicole E.
影响因子：
4.9
作者：
Fries JF;Krishnan E;Rose M;Lingala B;Bruce B
通讯作者：
Bruce B
CDC规定慢性疼痛的阿片类药物的指南 - 美国，2016年。
DOI：
10.1001/jama.2016.1464
发表时间：
2016-04-19
期刊：
JAMA
影响因子：
--
作者：
Dowell D;Haegerich TM;Chou R
通讯作者：
Chou R