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

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 该提案旨在解决膝骨性关节炎管理中的两个重要知识差距，以改善疼痛 和功能。促进体力活动被证明有助于减轻疼痛和改善功能 然而，在KOA中，缺乏可靠的方法来改变容易使用的行为。我们的团队已经 研究表明，社会激励源于行为经济学领域的概念推动 在其他环境中，改变行为和增加体力活动可能既实用又有效。这个 使用这些方法激励体力活动的有效性和安全性尚未在患者中进行研究。 和KOA一起。此外，辅助治疗，如皮质类固醇注射是否有助于减少 疼痛和残疾以及增加体力活动是未知的，这是一个额外的知识差距，由 目前的提案。尽管广泛使用，但确切的数据来量化皮质类固醇的益处，如果有的话。 缺乏注射。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 患者报告疼痛的时间为2年。这项研究表明，相比于 激素组在MRI上表现为生理盐水和软骨厚度小幅下降。这些数据可能表明 注射皮质类固醇弊大于利，然而，这也有严重的弱点。 包括疼痛和功能在内的研究仅每隔3个月进行一次评估，而之前的试验已经 建议收益高峰期为4-8周。我们建议用以下方式来填补这些重要的知识空白 创新高效的务实学习。目标是(1)确定基于以下条件的激励 行为增强的游戏化可以改善膝关节骨性关节炎患者的体力活动 减少自我报告的疼痛和残疾，以及(2)确定皮质类固醇注射是否可以减少 与单纯利多卡因相比，膝关节骨性关节炎患者的疼痛和残疾。这是双目的 使用析因和交叉设计对220名患者进行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取重要的患者报告结果。我们会 随机让参与者接受社会奖励，通过游戏化来促进身体活动的增加。 每位患者还将按随机顺序接受皮质类固醇和生理盐水治疗。我们将利用创新的移动 通过Way-to-HealthTM平台和评估为智能手机和可穿戴活动跟踪器提供应用程序， 实时了解干预措施对患者报告的功能和疼痛以及体力活动的影响。 该技术将允许在结果发生时记录结果，从而避免因以下原因而产生的信息偏差 回忆不好。这项研究将确定社会激励对促进体能提高的好处 KOA患者的活动度，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。我们由RR&D资助的试验研究证明了高度的可行性和 为更大规模的研究提供了重要的初步数据。这项研究包括来自 多种学科，并利用现有网络和基础设施，通过 强大的组织结构和调查人员之间的密切合作。

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.