Simons Laura E, Hess Courtney W, Choate Ellison S, Van Orden Amanda R, Tremblay-McGaw Alexandra G, Menendez Maria, Boothroyd Derek B, Parvathinathan Gomathy, Griffin Anya, Caruso Thomas J, Stinson Jennifer, Weisman Amy, Liu Timothy, Koeppen Kurt
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Stanford, CA, United States.
Quantitative Statistical Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA, United States.
JMIR Res Protoc. 2022 Dec 12;11(12):e40705. doi: 10.2196/40705.
Chronic musculoskeletal (MSK) pain is a prominent health concern, resulting in pain-related disability, loss of functioning, and high health care costs. Physiotherapy rehabilitation is a gold-standard treatment for improving functioning in youth with chronic MSK pain. However, increasing physical activity can feel unattainable for many adolescents because of pain-related fear and movement avoidance. Virtual reality (VR) offers an immersive experience that can interrupt the fear-avoidance cycle and improve engagement in physiotherapy. Despite promising initial findings, data are limited and often lack the rigor required to establish VR as an evidence-based treatment for MSK pain.
This trial evaluates physiorehabilitation with VR in adolescents with MSK pain. This protocol outlines the rationale, design, and implementation of a randomized controlled trial enhanced with a single-case experimental design.
This study is a 2-group randomized controlled trial assessing the use of physiorehabilitation with VR in adolescents with MSK pain. The authors will collaborate with physical therapists to integrate VR into their standard clinical care. For participants enrolled in standard physiotherapy, there will be no VR integrated into their physical therapy program. Primary outcomes include physical function and engagement in VR. Secondary outcomes include pain-related fear and treatment adherence. Moreover, we will obtain clinician perspectives regarding the feasibility of integrating the intervention into the flow of clinical practice.
The pilot study implementing physiorehabilitation with VR demonstrated that high engagement and use of physiorehabilitation with VR were associated with improvements in pain, fear, avoidance, and function. Coupled with qualitative feedback from patients, families, and clinicians, the pilot study results provide support for this trial to evaluate physiorehabilitation with VR for youth with chronic MSK pain. Analysis of results from the main clinical trial will begin as recruitment progresses, and results are expected in early 2024.
Significant breakthroughs for treating MSK pain require mechanistically informed innovative approaches. Physiorehabilitation with VR provides exposure to progressive challenges, real-time feedback, and reinforcement for movement and can include activities that are difficult to achieve in the real world. It has the added benefit of sustaining patient motivation and adherence while enabling clinicians to use objective benchmarks to influence progression. These findings will inform the decision of whether to proceed with a hybrid effectiveness-dissemination trial of physiorehabilitation with VR, serving as the basis for potential large-scale implementation of physiorehabilitation with VR.
ClinicalTrials.gov NCT04636177; https://clinicaltrials.gov/ct2/show/NCT04636177.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40705.
慢性肌肉骨骼疼痛是一个突出的健康问题,会导致与疼痛相关的残疾、功能丧失以及高昂的医疗费用。物理治疗康复是改善慢性肌肉骨骼疼痛青少年功能的金标准治疗方法。然而,由于与疼痛相关的恐惧和运动回避,增加身体活动对许多青少年来说可能难以实现。虚拟现实(VR)提供了一种沉浸式体验,可以中断恐惧 - 回避循环并提高对物理治疗的参与度。尽管初步研究结果很有前景,但数据有限,且往往缺乏将VR确立为基于证据的肌肉骨骼疼痛治疗方法所需的严谨性。
本试验评估VR在患有肌肉骨骼疼痛的青少年中的物理康复效果。本方案概述了一项采用单病例实验设计强化的随机对照试验的基本原理、设计和实施。
本研究是一项两组随机对照试验,评估VR在患有肌肉骨骼疼痛的青少年中的物理康复应用。作者将与物理治疗师合作,将VR整合到他们的标准临床护理中。对于参加标准物理治疗的参与者,其物理治疗方案中不会整合VR。主要结局包括身体功能和对VR的参与度。次要结局包括与疼痛相关的恐惧和治疗依从性。此外,我们将获取临床医生对将该干预措施整合到临床实践流程中的可行性的看法。
实施VR物理康复的初步研究表明,高参与度和使用VR进行物理康复与疼痛、恐惧、回避和功能的改善相关。结合患者、家庭和临床医生的定性反馈,初步研究结果为该试验评估VR对患有慢性肌肉骨骼疼痛的青少年的物理康复提供了支持。随着招募工作的推进,将开始对主要临床试验结果进行分析,预计2024年初得出结果。
治疗肌肉骨骼疼痛的重大突破需要基于机制的创新方法。VR物理康复提供了逐步挑战、实时反馈以及对运动的强化训练,并且可以包括在现实世界中难以实现的活动。它还有维持患者动力和依从性的额外好处,同时使临床医生能够使用客观基准来影响治疗进展。这些发现将为是否进行VR物理康复的混合有效性 - 传播试验的决策提供参考,作为VR物理康复潜在大规模实施的基础。
ClinicalTrials.gov NCT04636177;https://clinicaltrials.gov/ct2/show/NCT04636177。
国际注册报告标识符(IRRID):DERR1-10.2196/40705。