Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.
Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.
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DOI：
10.1136/bmjopen-2021-050545
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发表时间：
2021-06-15
期刊：
影响因子：
2.9
通讯作者：
Spiegel B
中科院分区：
文献类型：
--
作者：
Birckhead B;Eberlein S;Alvarez G;Gale R;Dupuy T;Makaroff K;Fuller G;Liu X;Yu KS;Black JT;Ishimori M;Venuturupalli S;Tu J;Norris T;Tighiouart M;Ross L;McKelvey K;Vrahas M;Danovitch I;Spiegel B
慢性疼痛非常普遍，并与巨大的疾病负担有关;迫切需要安全、基于家庭的非药物干预措施。虚拟现实（VR）是一种已知对急性疼痛有效的数字治疗方法，但其在慢性疼痛中的作用尚未完全阐明。在这里，我们提出了一个协议的国家卫生研究院（NIH）背痛联盟（BACPAC）VR试验，评估三种形式的VR的有效性慢性下腰痛（cLBP），慢性疼痛的一种高度流行的形式的患者。NIH BACPAC VR试验将360名cLBP患者随机分为三组，每组通过头戴式显示器进行管理：1）基于技能的VR，这是一种使用嵌入式生物识别传感器的认知行为疗法，正念冥想和生理生物反馈疗法的原则; 2）基于分心的VR，这是一种使用360度沉浸式视频的程序，旨在分散用户对疼痛的注意力;以及3）假VR，一种在VR头戴设备内使用二维视频的非沉浸式程序。研究参与者将使用通过REDCap（研究电子数据捕获）管理的患者报告结果，通过Fitbit Charge 4收集的可穿戴传感器数据和电子健康记录数据进行12周的监测。主要结局将是NIH患者报告结局测量信息系统（PROMIS）疼痛干扰量表。次要结局将包括PROMIS焦虑、PROMIS睡眠障碍、阿片类药物处方数据和疼痛灾难性量表简表。亚组分析将探索VR疗效的患者水平预测因素。于二零二零年四月获得Cedars-Sinai Health System的机构审查委员会的伦理批准。研究结果将在一份同行评审期刊上公布。NCT 04409353。
Chronic pain is highly prevalent and associated with a large burden of illness; there is a pressing need for safe, home-based, non-pharmacological, interventions. Virtual reality (VR) is a digital therapeutic known to be effective for acute pain, but its role in chronic pain is not yet fully elucidated. Here we present a protocol for the National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial that evaluates the effectiveness of three forms of VR for patients with chronic lower back pain (cLBP), a highly prevalent form of chronic pain. The NIH BACPAC VR trial will randomise 360 patients with cLBP into one of three arms, each administered through a head-mounted display: 1) skills-based VR, a program incorporating principles of cognitive behavioural therapy, mindful meditation and physiological biofeedback therapy using embedded biometric sensors; 2) distraction-based VR, a program using 360-degree immersive videos designed to distract users from pain; and 3) sham VR, a non-immersive program using two-dimensional videos within a VR headset. Research participants will be monitored for 12 weeks using a combination of patient-reported outcomes administered via REDCap (Research Electronic Data Capture), wearable sensor data collected via Fitbit Charge 4 and electronic health record data. The primary outcome will be the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale. Secondary outcomes will include PROMIS Anxiety, PROMIS Sleep Disturbance, opioid prescription data and Pain Catastrophizing Scale Short Form. A subgroup analysis will explore patient level predictors for VR efficacy. Ethics approval was obtained from the Institutional Review Board of Cedars-Sinai Health System in April 2020. The results will be disseminated in a peer-reviewed journal. NCT04409353.
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DOI：
10.1177/1539449218817291
发表时间：
2019-04-01
期刊：
OTJR-OCCUPATION PARTICIPATION AND HEALTH
影响因子：
--
作者：
Benham, Sara;Kang, Minhee;Grampurohit, Namrata
通讯作者：
Grampurohit, Namrata
影响因子：
3
作者：
Luo, XM;Pietrobon, R;Hey, L
通讯作者：
Hey, L
影响因子：
7.4
作者：
Hoffman, HG;Doctor, JN;Furness, TA
通讯作者：
Furness, TA
影响因子：
7.2
作者：
Askew RL;Cook KF;Revicki DA;Cella D;Amtmann D
通讯作者：
Amtmann D
影响因子：
2.9
作者：
KING, SA;STRAIN, JJ
通讯作者：
STRAIN, JJ