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

确定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: 10631882
• 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: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10631882
• 关键词: Accelerometer; Address; Adrenal Cortex Hormones; Analgesics; Arthritis; Behavioral; Biological; Cartilage; Chronic; Clinic Visits; Clinical; Clinical Trials; Clinical effectiveness; Crossover Design; Data; Disease Progression; Double-Blind Method; Effectiveness of Interventions; Exercise; Exercise Therapy; Fatigue; Feasibility Studies; Functional disorder; Goals; Health; Incentives; Individual; Inflammatory Arthritis; Infrastructure; Injections; Intervention; Knee Osteoarthritis; Knowledge; Lead; Magnetic Resonance Imaging; Measures; Mediating; Medical; Metabolic; Monitor; Morbidity - disease rate; Obesity; Outcome; Outcome Assessment; Pain; Participant; Patient Outcomes Assessments; Patients; Physical Function; Physical activity; Pilot Projects; Population; Practical trial; Pragmatic clinical trial; Provider; Randomized; Randomized Clinical Trials; Replacement Arthroplasty; Reporting; Research Design; Research Personnel; Resources; Safety; Saline; Subgroup; Symptoms; Technology; Testing; Thick; Time; Veterans; behavioral economics; career; cost; design; disability; effective therapy; experience; feasibility testing; improved; improved functioning; innovation; mobile application; mortality; multi-site trial; osteoarthritis pain; pain reduction; pragmatic implementation; pragmatic trial; randomized trial; recruit; response; side effect; smartphone Application; social

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.

项目摘要 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 一项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KOA的管理差距，以改善疼痛和功能。促进身体活动一直是 显示有助于减轻疼痛和改善KOA的功能。我们的研究表明， 从行为经济学领域的概念中衍生出的激励措施，以促进行为改变， 在其他环境中，增加身体活动既实用又有效。的疗效和安全性 尚未在KOA患者中研究使用这些方法激励体力活动。此外，委员会认为， 是否辅助治疗，如皮质类固醇注射可能有助于促进体力活动， 这是一个未知的问题，也是当前提案所解决的另一个知识差距。尽管广泛使用， 缺乏量化皮质类固醇注射的益处（如果有的话）的明确数据。一项大型随机试验 测试了每3个月注射皮质类固醇对患者报告的疼痛的影响，持续2年。 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 在皮质类固醇组的MRI上。这些数据可能表明，皮质类固醇注射导致更多的伤害， 然而，这项研究也有一些关键的弱点，包括疼痛和功能仅仅是 每3个月评估一次，而以前的试验表明，预期在4-8个月时达到峰值效益。 周我们建议用创新和有效的语用学研究来填补这些重要的知识空白。 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 宾夕法尼亚大学创新中心提供的资源，以获取重要的患者报告结局， 实时32位参与者我们将随机分配参与者，通过游戏化获得社会激励， 促进身体活动的增加。每例患者还将随机接受皮质类固醇和生理盐水 秩序我们将利用创新的移动的应用程序的智能手机和可穿戴活动跟踪器，通过 Way-to-HealthPTMP平台，并真实的实时评估干预措施对患者报告功能的影响 疼痛和体力活动。该技术将允许记录结果，因为它们发生， 从而避免了由于回忆不良而导致的信息偏差。这项研究将确定社会效益 激励措施，以促进KOA患者体力活动的增加，并确定 皮质类固醇注射用于改善功能、增加体力活动和减轻疼痛。结果 拟议的研究将提供初步数据，以支持一个大的，可行的，低成本的实用多地点试验。