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: 10216546
• 负责人: Brennan Spiegel
• 金额: $ 119.95万
• 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/10216546
• 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; Esthesia; Evidence based treatment; Functional Magnetic Resonance Imaging; Goggles; Harm Reduction; Head; Health; Heart Rate; High Performance Computing; Hydromorphone; Immersion; Impairment; Individual; Intervention; 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; 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; base; burden of illness; chronic pain; comorbidity; cost; disability; distraction; emotional functioning; falls; 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.

项目概要 慢性腰痛 (cLBP) 是一种普遍且昂贵的疾病，会严重损害身体、情绪、 尽管有巨大的疾病负担，但四分之一的成年人报告经常回来。 疼痛，可用的药物疗法提供持久益处和改善健康相关的能力有限 当其他药物治疗无效时，cLBP 患者经常转向阿片类药物。 提供足够的镇痛，但经常发现阿片类药物也无法有效减轻疼痛 因此，cLBP 的疼痛管理存在重大差距，解决这一问题至关重要； 证据差距的方式可以最大限度地提高患者的利益，同时最大限度地减少药物治疗的危害。 治疗虚拟现实 (VR) 已成为一种有前途且基于证据的治疗方式 肌肉骨骼疼痛，包括 cLBP，VR 用户佩戴一副近距离立体护目镜。 通过刺激身体，营造出一种进入栩栩如生的三维世界的感觉。 视觉皮层同时参与其他感官，VR 调节用户对伤害性刺激的处理。 大脑磁共振成像（fMRI）显示 VR 对感觉和岛叶有类似的影响 大脑皮层作为阿片类药物，头对头试验表明 VR 可以达到与氢吗啡酮相似或更好的镇痛效果。 然而，关于 VR 在 cLBP 中的长期疗效和安全性的数据很少。迄今为止，VR 的作用有限。 此外，除了分散注意力之外，对 VR 模式的研究也很有限。 作为 VR 疗法，使用认知行为疗法 (CBT)、引导冥想和 基于生物反馈的呼吸练习。 为了弥补这些差距，我们建议衡量患者报告的结果（PRO）、生物识别结果和 360 名非特异性 cLBP 患者使用阿片类药物，随机分为 3 组并随访 90 天：(1) 沉浸式 基于技能的 VR 治疗；(2) 沉浸式分心 VR 治疗；以及 (3) 使用 2D 视频的非沉浸式假 VR 治疗 结果将显示在 VR 耳机中，为在 cLBP 中实施 VR 的最佳实践提供信息并确定。 患者水平的疗效预测因子。