A Pragmatic Trial to Determine the Benefit of Behaviorally Enhanced Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee

确定行为强化运动激励和皮质类固醇注射对膝骨关节炎的益处的务实试验

• 批准号: 10312284
• 负责人: JOSHUA F. BAKER
• 金额: --
• 依托单位: PHILADELPHIA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2025-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10312284
• 关键词: Accelerometer; Address; Adrenal Cortex Hormones; Analgesics; Area; Arthritis; Behavioral; Biological; Cartilage; Chronic; Clinic Visits; Clinical; Clinical Trials; Clinical effectiveness; Collaborations; Country; Crossover Design; Data; Discipline; Disease Progression; Double-Blind Method; Effectiveness of Interventions; Elements; Ensure; Exercise; Exercise Therapy; Fatigue; Feasibility Studies; Functional disorder; Funding; Goals; Health; Incentives; Inflammatory Arthritis; Infrastructure; Injections; Intervention; Knee Osteoarthritis; Knowledge; Lead; Lidocaine; Magnetic Resonance Imaging; Measures; Mediating; Medical; Metabolic; Morbidity - disease rate; Network Infrastructure; Obesity; Outcome; Outcome Assessment; Pain; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Physical Function; Physical activity; Pilot Projects; Play; Population; Provider; Quality of life; Randomized; Randomized Clinical Trials; Replacement Arthroplasty; Reporting; Research Design; Research Personnel; Resources; Safety; Saline; Subgroup; Symptoms; Technology; Testing; Thick; Time; Veterans; base; behavior change; behavioral economics; cost; design; disability; effective therapy; experience; improved; improved functioning; innovation; mobile application; mortality; organizational structure; osteoarthritis pain; pain reduction; pragmatic trial; randomized trial; recruit; rehabilitation research; response; satisfaction; side effect; smartphone Application; social

Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among veterans and accounts for high morbidity and high costs for the VA. Importantly, chronic reductions in physical activity in patients with KOA may worsen pain, physical function, and exacerbate the metabolic consequences of obesity. The current proposal aims to address two important knowledge gaps in the management of KOA in order to improve pain and function. Promoting physical activity has been shown to be helpful in reducing pain and improving function in KOA, however, reliable ways to change behavior that can be easily employed are lacking. Our group has shown that social incentives derived from concepts from the field of behavioral economics to promote behavioral change and increase physical activity can be both practical and effective in other settings. The efficacy and safety of incentivizing physical activity using these approaches has not been studied in patients with KOA. Furthermore, whether adjunct therapies such as corticosteroid injections may be a helpful to reduce pain and disability and increase physical activity is unknown and is an additional knowledge gap addressed by the current proposal. Despite widespread use, definitive data to quantifying the benefit, if any, of corticosteroid injections are lacking. A large randomized trial tested the effects of corticosteroids injections every 3 months for a period of 2 years on patient reported pain. This study demonstrated no improvement in pain compared to saline and a small decline in cartilage thickness on MRI in the corticosteroid group. These data might suggest that corticosteroid injections result in more harm than good, however, there are critical weaknesses to this study including that pain and function were only assessed at 3-month intervals, while previous trials have suggested that peak benefit is expected at 4-8 weeks. We propose to fill these important knowledge gaps with an innovative and efficient pragmatic study. The aims are (1) To determine whether an incentive based on behaviorally-enhanced gamification can improve physical activity among patients with KOA and reduce self-reported pain and disability, and (2) to determine if corticosteroid injections can reduce pain and disability in patients with KOA when compared to lidocaine only. This double-blinded randomized clinical trial of 220 patients using a factorial and crossover design will leverage unique resources available through the Penn Center for Innovation to capture important patient-reported outcomes. We will randomize participants to receive social incentives with gamification to promote increases in physical activity. Each patient will also receive both corticosteroids and saline in random order. We will utilize innovative mobile applications for smart phones and wearable activity trackers through the Way-to-HealthTM platform and assess, in real time, the impact of the interventions on patient-reported function and pain as well as physical activity. The technology will allow for the recording of outcomes as they occur, thereby avoiding information bias due to poor recall. The study will determine the benefit of social incentivization to promote increases in physical activity in patients with KOA and to determine the efficacy of corticosteroid injections for improving function, increasing physical activity, and reducing pain. Our RR&D funded pilot study demonstrated high feasibility and provided important preliminary data to accurately power the larger study. The study includes experts across multiple disciplines and also leverages existing networks and infrastructure that will ensure feasibility through a strong organizational structure and close collaboration between investigators.

膝关节骨关节炎（KOA）是退伍军人和帐户中最普遍和致残的条件之一 高发病率和高成本的VA。重要的是，慢性减少体力活动的患者， KOA可能会加重疼痛，身体功能，并加剧肥胖的代谢后果。当前 该提案旨在解决KOA管理中的两个重要知识缺口，以改善疼痛 和功能促进身体活动已被证明有助于减轻疼痛和改善功能 然而，在KOA中，缺乏可以容易使用的改变行为的可靠方法。我们集团 表明社会激励来自行为经济学领域的概念， 行为改变和增加身体活动在其他环境中既实用又有效。的 尚未在患者中研究使用这些方法激励体力活动的有效性和安全性 关于KOA此外，是否辅助治疗，如皮质类固醇注射可能有助于减少 疼痛和残疾以及增加体力活动是未知的，是通过以下方法解决的另一个知识差距： 目前的提案。尽管广泛使用，但量化皮质类固醇获益（如果有的话）的确切数据 缺少注射剂。一项大型随机试验测试了每3个月注射一次皮质类固醇的效果 持续2年，患者报告疼痛。这项研究表明，与对照组相比， 皮质类固醇组的MRI显示软骨厚度略有下降。这些数据可能表明 皮质类固醇注射的结果弊大于利，然而，这也有关键的弱点， 包括疼痛和功能在内的研究只在3个月的时间间隔内进行评估，而以前的试验 这表明，预期在4-8周时达到峰值效益。我们建议填补这些重要的知识空白， 创新高效的务实学习。其目的是（1）确定是否基于激励措施， 行为增强游戏化可以改善KOA患者的体力活动， 减少自我报告的疼痛和残疾，（2）确定皮质类固醇注射是否可以减少 与仅利多卡因相比，KOA患者的疼痛和残疾。这双盲 采用析因和交叉设计的220例患者的随机临床试验将利用独特的资源 可通过宾夕法尼亚创新中心获得，以获取重要的患者报告结果。我们将 随机化参与者，以获得游戏化的社会激励，以促进身体活动的增加。 每例患者还将以随机顺序接受皮质类固醇和生理盐水。我们将利用创新的移动的 通过Wayto-HealthTM平台应用于智能手机和可穿戴活动追踪器并评估， 真实的时间，干预措施对患者报告的功能和疼痛以及身体活动的影响。 该技术将允许在结果发生时记录结果，从而避免由于以下原因而产生的信息偏差 记忆力差。这项研究将确定社会激励措施对促进身体健康的好处。 活动，并确定皮质类固醇注射改善功能的疗效， 增加体力活动，减轻疼痛。我们的RR&D资助的试点研究证明了高度的可行性， 为更大规模的研究提供了重要的初步数据。该研究包括专家在 多个学科，并利用现有的网络和基础设施，通过 强有力的组织结构和调查人员之间的密切合作。