Virtual Immersive Gaming to Optimize Recovery in Low Back Pain

虚拟沉浸式游戏可优化腰痛恢复

• 批准号: 10558448
• 负责人: Christopher R France
• 金额: $ 48.12万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-11-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10558448
• 关键词: Accelerometer; Acute; Address; Adoption; Aftercare; Back Pain; Chronic; Chronic low back pain; Clinical; Connective Tissue; Control Groups; Data; Development; Environment; Exhibits; Expectancy; Fright; Goals; Health Services Accessibility; Hip region structure; Individual; Individual Differences; Injury; Intervention; Intractable Pain; Knee; Laboratories; Low Back Pain; Maintenance; Measures; Medical Care Costs; Monitor; Motion; Movement; Muscle; Outcome; Pain; Participant; Patients; Pattern; Persistent pain; Phase; Physicians; Play; Public Health; Randomized; Recovery; Risk; Shoulder; Spinal; Standardization; Technology; Testing; Time; United States; United States National Institutes of Health; Vertebral column; Video Games; Visit; arm; chronic painful condition; comparison control; cost; design; disability; efficacy evaluation; expectation; experimental group; follow-up; gaming environment; improved; innovation; novel strategies; pain patient; pain reduction; phase I trial; phase II trial; restoration; standard of care; virtual; virtual reality environment; virtual reality game

Abstract Low back pain is the second most common reason for a visit to a physician, with direct medical costs exceeding $90 billion per year in the United States alone. These costs are driven primarily by 7-10% of patients who develop a chronic pain disorder that can last for many years. Fear of movement (i.e., kinesiophobia) due to expectations of pain and harm is an important risk indicator for the development of persistent pain and disability, with studies consistently showing that high fear is one of the strongest predictors of the transition to chronic low back pain (CLBP). Specifically, fear encourages the adoption of maladaptive movement patterns wherein tasks of daily living are performed with reduced lumbar spine flexion and compensatory increases of knee, hip, and arm shoulder flexion. While avoidance of lumbar flexion may benefit these back pain sufferers in the short-term by reducing their fear of injury, in the long-term limited lumbar flexion becomes an entrenched pattern that can lead to shortening of spinal peri-articular connective tissues, changes in surrounding muscles, and increased risk for chronicity. With the support of an NIH R21, we recently completed a Phase I trial of an immersive virtual reality dodgeball game designed specifically to increase lumbar flexion among individuals with CLBP and high fear of movement. The results of this proof-of-concept study demonstrated that 3 daily sessions of virtual dodgeball was safe, did not exacerbate existing back pain, was highly rated by participants, and increased lumbar spine flexion during gameplay. We now propose a Phase II RCT to determine the efficacy of a 9–week course of treatment of virtual dodgeball to reduce pain and disability. CLBP participants will be randomly assigned to play one of two versions of our virtual reality game. In the experimental group, gameplay will promote progressive increases in lumbar flexion. The control group will play the same immersive video game, but the parameters of the game will be modified such that only small excursions of lumbar flexion are needed to successfully complete gameplay. The co-primary clinical outcomes of changes in pain and disability will be assessed at 1-, 6-, 12-, 24-, and 48-weeks post-treatment. Additionally, individual differences in expected pain, expected harm, and lumbar flexion will be measured at pre-treatment baseline and at each of the follow-up intervals in the laboratory. Finally, participant activity in their natural environment will be monitored for 7 days following each follow-up laboratory visit. We have developed an innovative immersive video game that safely reduces expectations of pain/harm and increases lumbar flexion among individuals with CLBP. The proposed Phase II trial will have a significant impact on public health by testing the ability of this unique intervention to motivate CLBP sufferers to re-engage in the specific spinal motions necessary to promote recovery and to maintain these treatment gains.

摘要 腰痛是看医生的第二大常见原因，直接医疗费用超过 仅在美国每年就有900亿美元。这些成本主要是由7%-10%的患者推动的 患上一种可持续多年的慢性疼痛障碍。由于以下原因而害怕运动(即运动恐惧症) 对疼痛和伤害的预期是发展持续性疼痛和伤害的重要风险指标 残疾，研究一直表明高度恐惧是过渡到 慢性腰痛(CLBP)。具体地说，恐惧会鼓励人们采用不适应的运动模式 其中日常生活任务是通过减少腰椎屈曲和代偿性增加 膝关节、臀部和手臂肩部屈曲。虽然避免腰椎屈曲可能会使这些背痛患者在 短期内通过减少对受伤的恐惧，在长期内有限的腰椎屈曲成为根深蒂固的 可导致脊柱关节周围结缔组织缩短，周围肌肉改变， 并增加了慢性病的风险。 在NIH R21的支持下，我们最近完成了沉浸式虚拟现实躲避球的第一阶段试验 这款游戏专为增加患有CLBP和运动恐惧症患者的腰部屈曲度而设计。 这项概念验证研究的结果表明，每天3次虚拟躲避球是安全的，是吗？ 不会加剧现有的背部疼痛，被参与者高度评价，并在 游戏性。我们现在提出一项II期随机对照试验，以确定9周疗程的虚拟 躲避球，以减少疼痛和残疾。CLBP参与者将被随机分配到两个版本中的一个 我们的虚拟现实游戏。在试验组中，玩游戏将促进腰椎进行性增加 屈曲。对照组将玩同样的沉浸式视频游戏，但游戏的参数将是 经过修改，只需要小幅度的腰部屈曲就能成功完成游戏。这个 疼痛和残疾变化的共同主要临床结果将在1、6、12、24和48周进行评估 后处理。此外，预期疼痛、预期伤害和腰椎屈曲方面的个体差异将是 在治疗前基线和实验室中的每个随访间隔进行测量。最后，参与者 在每次后续实验室访问后，将对其自然环境中的活动进行为期7天的监测。 我们开发了一款创新的沉浸式视频游戏，可以安全地降低痛苦/伤害的预期，并 增加CLBP患者的腰椎屈曲度。拟议的第二阶段试验将产生重大影响 通过测试这一独特干预措施的能力来激励慢性阻塞性肺病患者重新参与 促进康复和维持这些治疗成果所需的特定脊椎运动。

项目成果

Corrigendum to "Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial" [Contemporary Clinical Trials 69 (2018) 83-91].

“虚拟沉浸式游戏优化腰痛恢复 (VIGOR)：II 期随机对照试验”的勘误表 [当代临床试验 69 (2018) 83-91]。

• DOI: 10.1016/j.cct.2020.106120
• 发表时间: 2020
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: France,ChristopherR;Thomas,JamesS
• 通讯作者: Thomas,JamesS