A Pragmatic Trial to Determine the Benefit of Exercise Incentives and Corticosteroid Injections for Osteoarthritis of the Knee

项目总结 膝关节骨关节炎(KOA)是退伍军人和退伍军人中最常见和最致残的疾病之一 因为退伍军人事务部的高发病率和高成本。重要的是，慢性体力活动减少的患者 膝关节骨性关节炎可能会加剧疼痛、身体功能，并加剧肥胖症的代谢后果。海流 该提案旨在获得初步数据，以支持一项大型务实试验，以解决两个重要知识 在膝关节骨性关节炎的管理方面存在差距，以改善疼痛和功能。促进体育锻炼一直以来都是 有助于减轻膝关节骨性关节炎患者的疼痛和改善其功能。我们的团队已经表明，社交 从行为经济学领域的概念衍生出来的激励措施，以促进行为改变和 在其他环境中，增加体力活动既实用又有效。该药的有效性和安全性 在膝关节骨性关节炎患者中还没有研究过使用这些方法来激励体力活动。此外， 辅助疗法，如皮质类固醇注射是否有助于促进体力活动 这是一个未知的问题，是当前提案所解决的一个额外的知识差距。尽管被广泛使用， 缺乏明确的数据来量化皮质类固醇注射的益处(如果有的话)。一项大型随机试验 测试为期2年的每3个月注射一次皮质类固醇对患者报告的疼痛的影响。 这项研究表明，与生理盐水相比，疼痛没有改善，软骨厚度略有下降。 皮质类固醇组的MRI。这些数据可能表明，注射皮质类固醇会导致更大的危害 然而，这项研究还有一些关键的弱点，包括疼痛和功能只是 每隔3个月评估一次，而之前的试验表明，预期4-8个月为受益高峰 几周。我们建议用创新和高效的语用研究来填补这些重要的Unowledge GapsU。 这项采用析因和交叉设计的双盲随机临床试验将利用独特的 通过宾夕法尼亚创新中心提供的资源，以获取重要的患者报告结果 实时在32个参与者中。我们将随机选择参与者，通过游戏化获得社会激励 促进增加体力活动。每位患者还将随机接受皮质类固醇和生理盐水。 秩序。我们将在智能手机和可穿戴活动跟踪器上使用创新的移动应用程序 Way-to-HealthPTMP平台，并实时评估干预措施对患者报告功能的影响 以及疼痛和体力活动。该技术将允许在结果发生时记录结果， 从而避免了由于查全率不高而导致的信息偏差。这项研究将确定社会福利 激励促进膝关节骨性关节炎患者增加体力活动并确定其疗效 用于改善功能、增加体力活动和减轻疼痛的皮质类固醇注射。调查结果： 拟议的研究将提供初步数据，为大规模、可行和低成本的务实多点试验提供动力。

PROJECT SUMMARY 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 derive preliminary data to support a large pragmatic trial 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. 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 promote physical activity is unknown and is an additional knowledge gap addressed by the current proposal. Despite widespread use, definitive data 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 Uknowledge gapsU with an innovative and efficient pragmatic study. This double-blinded randomized clinical trial using a factorial and crossover design will leverage unique resources available through the Penn Center for Innovation to capture important patient-reported outcomes in real-time in 32 participants. 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-HealthPTMP 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. Results from the proposed study will provide preliminary data to power a large, feasible, and low-cost pragmatic multi-site trial.