Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. Objective: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. Methods: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between–within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. Results: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ≥5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre–post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. Conclusions: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177

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中文翻译：

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针对慢性腰痛的为期 8 周的自我管理的基于行为技能的虚拟现实计划：在 COVID-19 期间进行的双盲、随机、安慰剂对照试验


背景：慢性腰痛是全世界最普遍的慢性疼痛，而行为疼痛治疗的机会有限。虚拟现实（VR）是一种沉浸式技术，可以为慢性疼痛提供有效的行为疗法。目的：我们旨在开展一项双盲、平行臂、单队列、远程、随机安慰剂对照试验，针对自我报告慢性腰痛的社区个体实施基于行为技能的 VR 项目在 COVID-19 大流行期间。方法：纳入全国在线便利样本，纳入自述非恶性腰痛、持续时间为 6 个月或以上且平均疼痛强度为 4 或以上/10 的个体，并按每天 2 次中的 1:1 随机分组（56-天）VR方案：（1）EaseVRx（沉浸式止痛技能VR方案）； (2) Sham VR（通过 VR 耳机传送的 2D 自然内容）。收集客观设备使用数据和自我报告数据。主要结果是 EaseVRx 与 Sham VR 在不同时间点上的组间效应，以及代表平均疼痛强度变化的组内交互效应以及随时间推移对活动、压力、情绪和睡眠的疼痛相关干扰（基线）至第 56 天治疗结束）。次要结果是对身体功能变化和变化的总体印象、睡眠障碍、疼痛自我效能、疼痛灾难化、疼痛接受度、止痛药物使用和用户满意度。分析方法包括意向治疗和混合模型框架。结果：研究样本为 179 名成年人（女性：76.5%，137/179；白人：90.5%，162/179；至少受过大学教育：91.1%，163/179；平均年龄：51.5 岁 [SD 13.1]；平均疼痛强度：5/10 [SD 1。2];背痛持续时间≥5年：67%, 120/179)。没有发现任何基线变量或治疗参与度存在组间差异。 EaseVRx 的用户满意度高于 Sham VR (P<.001)。对于组间因素，EaseVRx 在所有主要结局方面均优于 Sham VR（最高 P 值=.009），组间 Cohen d 效应大小范围为 0.40 至 0.49，表明优越性具有中等临床意义。对于 EaseVRx，前后效应范围较大，范围为 1.17 至 1.3，对于降低疼痛强度以及疼痛相关的活动、情绪和压力干扰具有中度至显着的临床重要性。身体功能和睡眠障碍的组间比较显示 EaseVRx 组优于 Sham VR 组（分别为 P=0.022 和 0.013）。两组的疼痛灾难化、疼痛自我效能、疼痛接受度、处方阿片类药物使用（吗啡毫克当量）均未达到统计学显着性。 EaseVRx (P<.01) 的非处方镇痛药使用量有所减少，但 Sham VR 的使用量并未减少。结论：与假 VR 相比，EaseVRx 具有较高的用户满意度，并且在平均疼痛强度以及对活动、情绪和压力的疼痛相关干扰方面具有优越且具有临床意义的症状减轻。需要进行更多的研究来确定治疗效果的持久性并描述治疗效果的机制。家庭虚拟现实可能会扩大慢性腰痛的有效和按需非药物治疗的范围。试验注册：ClinicalTrials.gov NCT04415177； https://临床试验。政府/ct2/show/NCT04415177


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