一项为期 8 周的基于家庭的自我管理虚拟现实程序治疗慢性下腰痛的疗效持久性：一项随机临床试验的 6 个月随访研究。

Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial.

机构信息

AppliedVR, Van Nuys, CA, United States.

Johns Hopkins School of Medicine, Baltimore, MD, United States.

出版信息

J Med Internet Res. 2022 May 25;24(5):e37480. doi: 10.2196/37480.

BACKGROUND

We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding).

OBJECTIVE

This study assessed between-group and within-group treatment effects 6 months posttreatment to determine the extended efficacy, magnitude of efficacy, and clinical importance of home-based therapeutic VR.

METHODS

E-surveys were deployed at pretreatment, end-of-treatment, and posttreatment months 1, 2, 3, and 6. Self-reported data for 188 participants were analyzed in a mixed-model framework using a marginal model to allow for correlated responses across the repeated measures. Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment. Secondary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance and physical function.

RESULTS

Therapeutic VR maintained significant and clinically meaningful effects 6 months posttreatment and remained superior to sham VR for reducing pain intensity and pain-related interference with activity, stress, and sleep (d=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (d=0.34; P=.02 and d=0.46; P<.001, respectively). Participants were encouraged to contact study staff with any problems experienced during treatment; however, no participants contacted study staff to report adverse events of any type, including nausea and motion sickness.

CONCLUSIONS

Our 8-week home-based VR pain management program caused important reductions in pain intensity and interference up to 6 months after treatment. Additional studies are needed in diverse samples.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/25291.

背景

我们之前报告了一项为期 8 周的基于家庭的沉浸式虚拟现实（VR）治疗方案的疗效，这是一项双盲随机安慰剂对照研究。我们将自我报告患有慢性下腰痛的社区成年人随机分为 1:1 组，分别接受（1）56 天沉浸式治疗疼痛缓解技能 VR 方案（EaseVRx）或（2）56 天假 VR 方案。治疗后即刻的结果显示，治疗性 VR 优于假 VR，可降低疼痛强度；疼痛相关的活动、情绪、压力和睡眠障碍（但不包括睡眠）；身体功能；和睡眠障碍。治疗后 3 个月，治疗性 VR 仍保持对疼痛强度和与活动、压力和睡眠相关的疼痛干扰的优势（新发现）。

目的

本研究评估了治疗后 6 个月的组间和组内治疗效果，以确定基于家庭的治疗性 VR 的长期疗效、疗效幅度和临床重要性。

方法

在治疗前、治疗结束时和治疗后 1、2、3 和 6 个月进行电子调查。对 188 名参与者的自我报告数据进行了混合模型框架分析，使用边缘模型允许对重复测量进行相关响应。主要结局指标是治疗后 6 个月的疼痛强度和与活动、情绪、压力和睡眠相关的疼痛干扰。次要结局指标是患者报告的结局测量信息系统（PROMIS）睡眠障碍和身体功能。

结果

治疗性 VR 在治疗后 6 个月仍保持显著且具有临床意义的疗效，并继续优于假 VR，可降低疼痛强度和与活动、压力和睡眠相关的疼痛干扰（d=0.44-0.54；P<.003）。EaseVRx 组在身体功能和睡眠障碍方面优于假 VR 组（d=0.34；P=.02 和 d=0.46；P<.001）。参与者被鼓励在治疗期间遇到任何问题时与研究人员联系；然而，没有参与者联系研究人员报告任何类型的不良事件，包括恶心和运动病。