Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK).
Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK).
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DOI：
10.1186/s13063-022-06529-w
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发表时间：
2022-07-27
期刊：
影响因子：
2.5
通讯作者：
Baker, Joshua F.
中科院分区：
文献类型：
--
作者：
Leach, William;Doherty, Caleigh;Olave, Marianna;England, Bryant R.;Wysham, Katherine;Kerr, Gail;Quinones, Mercedes;Ogdie, Alexis;White, Dan;Neogi, Tuhina;Scanzello, Carla R.;Baker, Joshua F.
关键词：
膝关节骨关节炎（KOA）是老龄化人口中的一个高度优先的问题。虽然运动已被证明有利于疾病的管理，但缺乏可扩展的低成本干预措施来改善这一人群的运动。最近关于皮质类固醇注射用于缓解的价值的争论也出现了。因此，我们设计了一项随机、双盲、安慰剂对照的临床试验，采用2阶段交叉设计，研究（1）促进运动的行为激励和（2）与仅利多卡因相比，皮质类固醇注射在KOA患者中减轻疼痛和改善功能。研究设计是一项实用的析因和交叉随机临床试验。将从美国退伍军人事务部（VA）卫生系统内的四个地点的临床实践中招募被其提供者认为有资格接受膝关节注射并且能够在没有辅助设备的情况下行走的KOA患者。总共有220名参与者将随机接受游戏化的社会激励（即，结合游戏元素）以促进锻炼，并与接收Fitbit但没有激励的对照进行比较。每例患者还将被随机分配接受盲态皮质类固醇注射和仅利多卡因注射。主要结局是平均每日步数较基线的变化和膝关节骨关节炎结局评分（KOOS）较基线的变化。研究团队将在八个月的随访中每隔四个星期使用活动监测器连续收集步数、心率和睡眠数据，并使用Way to Health（WTH）平台连续收集患者报告的结果。将使用合并所有可用数据点的混合效应回归进行分析。“为膝关节骨关节炎退伍军人继续前进”（MOVE-OK）试验将采取务实的方法来评估（1）基于行为增强游戏化的激励措施是否可以改善该患者人群的体力活动，以及（2）皮质类固醇注射是否可以减轻KOA患者的疼痛和残疾。这项试验的结果将有助于指导临床实践和通知管理指南。ClinicalTrials.gov NCT 05035810。于二零二一年九月五日注册。在线版本包含补充材料，可通过10.1186/s13063-022-06529-w获得。
Knee osteoarthritis (KOA) is a high-priority problem among the aging population. While exercise has been shown to be beneficial in management of the disease, scalable and low-cost interventions to improve exercise in this population are lacking. Recent controversy over the value of corticosteroid injections for palliation has also arisen. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial with a 2-period crossover design to study (1) behavioral incentives to promote exercise and (2) corticosteroid injections to reduce pain and improve function in patients with KOA when compared to lidocaine only. The study design is a pragmatic factorial and crossover randomized clinical trial. Patients with KOA who are deemed eligible by their provider to receive knee injections and are able to walk without assistive devices will be recruited from clinical practices at four sites within the Veterans Affairs (VA) Health System in the USA. In total, 220 participants will be randomized to receive social incentives with gamification (i.e., incorporation of game elements) to promote exercise and compared to controls that receive a Fitbit but no incentive. Each patient will also be assigned to receive a blinded corticosteroid injection and a lidocaine-only injection in random order. The primary outcomes are the change in average daily step counts from baseline and the change in Knee Osteoarthritis Outcome Score (KOOS) from baseline. The study team will continuously collect step count, heart rate, and sleep data using activity monitors and patient-reported outcomes using the Way to Health (WTH) platform at two four-week intervals over eight months of follow-up. Mixed effects regression incorporating all available data points will be used for analysis. The “Marching on for Veterans with Osteoarthritis of the Knee” (MOVE-OK) trial will take a pragmatic approach to evaluate (1) whether incentives based on behaviorally enhanced gamification can improve physical activity in this patient population and (2) whether corticosteroids injections reduce pain and disability in patients with KOA. Results of this trial will help to direct clinical practice and inform management guidelines. ClinicalTrials.gov NCT05035810. Registered on 5 September 2021. The online version contains supplementary material available at 10.1186/s13063-022-06529-w.
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