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: 10378456
• 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/10378456
• 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 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.

项目概要 膝骨关节炎 (KOA) 是退伍军人和军人中最常见和最致残的疾病之一 VA 的高发病率和高成本。重要的是，长期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。目前的 该提案旨在得出初步数据，以支持大型务实试验，以解决两个重要知识问题 为了改善疼痛和功能而治疗 KOA 的差距。促进身体活动已 经证明有助于减轻 KOA 的疼痛和改善功能。我们的小组已经表明，社交 源于行为经济学领域概念的激励措施，以促进行为改变和 增加体力活动在其他情况下既实用又有效。功效和安全性 尚未在 KOA 患者中研究使用这些方法激励身体活动。此外， 皮质类固醇注射等辅助疗法是否有助于促进身体活动 未知，是当前提案解决的额外知识差距。尽管广泛使用， 目前尚缺乏量化皮质类固醇注射的益处（如果有的话）的明确数据。大型随机试验 测试了为期 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。这些数据可能表明皮质类固醇注射会造成更大的伤害 然而，这项研究存在一些严重的缺陷，包括疼痛和功能仅 每 3 个月进行一次评估，而之前的试验表明，预计 4-8 个月可获得最大益处 几周。我们建议通过创新和高效的务实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 通过宾夕法尼亚州创新中心提供的资源，以获取患者报告的重要结果 32 位参与者实时参与。我们将随机分配参与者以获得社会激励，并通过游戏化来 促进身体活动的增加。每个患者还将随机接受皮质类固醇和生理盐水 命令。我们将通过以下方式利用智能手机和可穿戴活动追踪器的创新移动应用程序 Way-to-HealthPTMP 平台并实时评估干预措施对患者报告的功能的影响 和疼痛以及体力活动。该技术将允许记录发生的结果， 从而避免因记忆不良而导致的信息偏差。该研究将确定社会效益 激励措施促进 KOA 患者体力活动的增加并确定疗效 皮质类固醇注射用于改善功能、增加体力活动和减轻疼痛。结果来自 拟议的研究将为大规模、可行且低成本的实用多地点试验提供初步数据。