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: 10267739
• 负责人: Brennan Spiegel
• 金额: $ 83.78万
• 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/10267739
• 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.

项目总结