Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity

虚拟现实治疗慢性腰痛的随机对照试验，以改善患者报告的结果和身体活动

• 批准号: 10896861
• 负责人: Brennan Spiegel
• 金额: $ 8.18万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-25 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10896861
• 关键词: 3D virtual reality; 3D world; Absence of pain sensation; Achievement; Acute Pain; Address; Adult; Back Pain; Biofeedback; Biometry; Brain imaging; Breathing Exercises; Burn injury; Calories; Chronic; Chronic low back pain; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Control Groups; Data; Devices; Economics; Educational process of instructing; Esthesia; Evidence based treatment; Functional Magnetic Resonance Imaging; Goggles; Harm Reduction; Head; Health; Heart Rate; High Performance Computing; Hydromorphone; Impairment; Individual; Intervention; Life; Linear Regressions; Literature; Logistic Regressions; Logit Models; Measures; Medical; Meditation; Mental Depression; Modality; Modeling; Monitor; Musculoskeletal Pain; Nociceptive Stimulus; Opiate Addiction; Opioid; Opioid Analgesics; Outcome; Pain; Pain interference; Pain management; Patient Outcomes Assessments; Patient Selection; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Pharmacotherapy; Photic Stimulation; Physical Function; Physical activity; Predictive Value; Protocols documentation; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Receiver Operating Characteristics; Reporting; Research; Risk; Safety; Sampling; Sensory; Severities; Sleep disturbances; Social Functioning; Testing; Therapeutic; Time; United States National Institutes of Health; Visual Cortex; burden of illness; chronic pain; comorbidity; cost; disability; distraction; emotional functioning; falls; health determinants; health related quality of life; improved; mortality; opioid use; opioid use disorder; pain patient; pain reduction; predictive modeling; primary outcome; psychological distress; response; skills; sleep quality; sleep quantity; sociodemographics; stereoscopic; treatment group; treatment response; two-dimensional; virtual environment; virtual reality; virtual reality environment; virtual reality headset

PROJECT SUMMARY Chronic low back pain (cLBP) is a prevalent and costly condition that markedly impairs physical, emotional, and social function. Despite its overwhelming burden of illness, with one in four adults reporting frequent back pain, available drug therapies are limited in their ability to provide lasting benefits and improve health-related quality of life (HRQOL). Patients with cLBP frequently turn to opioids when other pharmacotherapies fail to provide adequate analgesia, yet often discover that opioids also fall short in delivering meaningful pain reduction or improving HRQOL. Hence, there is a critical gap in pain management in cLBP; it is vital to address this evidence gap in a way that maximizes benefits for patients while minimizing harms from medical therapy. Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for musculoskeletal pain, including cLBP. Users of VR wear a pair of goggles with a close-proximity stereoscopic screen that creates a sensation of being transported into lifelike, three-dimensional worlds. By stimulating the visual cortex while engaging other senses, VR modulates the user’s processing of nociceptive stimuli. Functional magnetic resonance imaging (fMRI) of the brain reveals that VR has similar effects on the sensory and insular cortex as opioids, and head-to-head trials show that VR achieves similar or greater analgesia as hydromorphone. However, there are few data regarding long-term efficacy and safety of VR in cLBP. To date, VR has been limited to short-term clinical trials. In addition, limited research exists on VR modalities beyond mere distraction, such as VR therapy that teaches exportable skills using cognitive behavioral therapy (CBT), guided meditation, and biofeedback-based breathing exercises. To address these gaps, we propose to measure patient-reported outcomes (PROs), biometric outcomes, and opioid use in 360 nonspecific cLBP patients randomized among 3 groups and followed for 90 days: (1) immersive skills-based VR therapy; (2) immersive distraction VR therapy; and (3) non-immersive sham VR using 2D videos displayed in a VR headset. The results will inform best practices for implementing VR in cLBP and identify patient-level predictors of efficacy.

项目摘要 慢性下腰痛（CLBP）是一种普遍且昂贵的状况，明显损害身体，情感， 和社会功能。尽管疾病的压倒性烧伤，但四分之一的成年人经常报告 疼痛，可用的药物疗法的能力有限 生活质量（HRQOL）。当其他药物疗法无法 提供足够的镇痛药，但经常发现阿片类药物在减轻有意义的疼痛方面也缺乏 或改善HRQOL。因此，CLBP的疼痛管理存在很大的差距。解决这个问题至关重要 证据差距以最大化患者的益处，同时最大程度地减少医疗疗法危害的方式。 治疗性虚拟现实（VR）已成为一种承诺和基于证据的治疗方式 肌肉骨骼疼痛，包括CLBP。 VR的用户穿着一双镜头，带有近距离立体镜 屏幕会产生一种被运输到栩栩如生的三维世界的感觉。通过刺激 视觉皮层吸引其他感觉时，VR调节用户对伤害性刺激的处理。功能 大脑的磁共振成像（fMRI）揭示了VR对感觉和岛屿的影响相似 作为阿片类药物的皮质和头对头试验表明，VR的镇痛与氢球室相似或更大的镇痛。 但是，关于CLBP中VR的长期效率和安全性的数据很少。迄今为止，VR一直受到限制 短期临床试验。此外，关于VR模式的研究有限，仅仅是分散注意力， 作为VR疗法，使用认知行为疗法（CBT），指导冥想和 基于生物反馈的呼吸练习。 为了解决这些差距，我们建议衡量患者报告的结果（专业），生物识别结果和 360例非特异性CLBP患者在3组中随机分组，随后使用90天：（1）沉浸液 基于技能的VR疗法； （2）沉浸分散的VR治疗； （3）使用2D视频的非放入性假VR 显示在VR耳机中。结果将为在CLBP中实施VR的最佳实践提供信息并确定 患者级效率的预测指标。

项目成果

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.

• DOI: 10.1136/bmjopen-2021-050545
• 发表时间: 2021-06-15
• 期刊: BMJ open
• 影响因子: 2.9
• 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
• 通讯作者: Spiegel B