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.
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.
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8周自我管理的基于家庭的虚拟现实程序对慢性腰痛治疗效果的持久性：一项随机临床试验的6个月随访研究。
DOI：
10.2196/37480
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发表时间：
2022-05-25
影响因子：
7.4
通讯作者：
Darnall, Beth
中科院分区：
文献类型：
--
作者：
Garcia, Laura;Birckhead, Brandon;Krishnamurthy, Parthasarathy;Mackey, Ian;Sackman, Josh;Salmasi, Vafi;Louis, Robert;Castro, Carina;Maddox, Roselani;Maddox, Todd;Darnall, Beth
我们之前在一项双盲随机安慰剂对照研究中报道了为期 8 周的家庭沉浸式虚拟现实 (VR) 治疗方案的疗效。社区中自我报告患有慢性腰痛的成年人以 1:1 的比例随机接受 (1) 56 天的沉浸式治疗疼痛缓解技能 VR 计划 (EaseVRx) 或 (2) 56 天的假 VR 计划。治疗后立即结果显示，治疗性 VR 在减轻疼痛强度方面优于假 VR；与疼痛相关的活动、情绪和压力干扰（但不包括睡眠）；身体机能；和睡眠障碍。治疗后 3 个月，治疗性 VR 在减轻疼痛强度以及疼痛相关的活动、压力和睡眠干扰方面保持了优越性（新发现）。本研究评估了治疗后 6 个月的组间和组内治疗效果，以确定家庭治疗性 VR 的延长疗效、疗效程度和临床重要性。在治疗前、治疗结束和治疗后第 1、2、3 和 6 个月进行了电子调查。在混合模型框架中使用边际模型对 188 名参与者的自我报告数据进行了分析，以允许重复测量中的相关反应。主要结果是治疗后 6 个月时的疼痛强度以及疼痛相关的对活动、情绪、压力和睡眠的干扰。次要结果是患者报告结果测量信息系统（PROMIS）睡眠障碍和身体功能。治疗性 VR 在治疗后 6 个月保持了显着且具有临床意义的效果，并且在降低疼痛强度以及疼痛相关的活动、压力和睡眠干扰方面仍然优于假 VR（ds=0.44-0.54；P<.003）。身体功能和睡眠障碍的组间比较显示 EaseVRx 优于假 VR（分别为 ds=0.34；P=.02 和 ds=0.46；P<.001）。鼓励参与者在治疗期间遇到任何问题联系研究人员；然而，没有参与者联系研究人员报告任何类型的不良事件，包括恶心和晕动病。我们为期 8 周的家庭 VR 疼痛管理计划在治疗后 6 个月内显着降低了疼痛强度和干扰。需要对不同的样本进行额外的研究。 ClinicalTrials.gov NCT04415177； https://clinicaltrials.gov/ct2/show/NCT04415177 RR2-10.2196/25291
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). 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. 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. 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 (ds=0.44-0.54; P<.003). Between-group comparisons for physical function and sleep disturbance showed superiority of EaseVRx over sham VR (ds=0.34; P=.02 and ds=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. 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. ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 RR2-10.2196/25291
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影响因子：
3.8
作者：
Atzori, Barbara;Hoffman, Hunter G.;Grotto, Rosapia Lauro
通讯作者：
Grotto, Rosapia Lauro
影响因子：
4.9
作者：
Fries JF;Krishnan E;Rose M;Lingala B;Bruce B
通讯作者：
Bruce B
影响因子：
3.1
作者：
Yu L;Buysse DJ;Germain A;Moul DE;Stover A;Dodds NE;Johnston KL;Pilkonis PA
通讯作者：
Pilkonis PA
DOI：
10.3390/ijerph182211806
发表时间：
2021-11-11
影响因子：
--
作者：
Brea-Gómez B;Torres-Sánchez I;Ortiz-Rubio A;Calvache-Mateo A;Cabrera-Martos I;López-López L;Valenza MC
通讯作者：
Valenza MC
影响因子：
3.8
作者：
Fischer, H. Felix;Rose, Matthias
通讯作者：
Rose, Matthias