National Institute for Health Research, Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
Department of Health Sciences, Lund University, Lund University, Sweden.
JAMA Netw Open. 2021 Feb 1;4(2):e210012. doi: 10.1001/jamanetworkopen.2021.0012.
Osteoarthritis is a prevalent, debilitating, and costly chronic disease for which recommended first-line treatment is underused.
To compare the effect of an internet-based treatment for knee osteoarthritis vs routine self-management (ie, usual care).
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from October 2018 to March 2020. Participants included individuals aged 45 years or older with a diagnosis of knee osteoarthritis recruited from an existing primary care database or from social media advertisements were invited. Data were analyzed April to July 2020.
The intervention and control group conformed to first-line knee osteoarthritis treatment. For the intervention group, treatment was delivered via a smartphone application. The control group received routine self-management care.
The primary outcome was change from baseline to 6 weeks in self-reported pain during the last 7 days, reported on a numerical rating scale (NRS; range, 0-10, with 0 indicating no pain and 10, worst pain imaginable), compared between groups. Secondary outcomes included 2 physical functioning scores, hamstring and quadriceps muscle strength, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and quantitative sensory testing.
Among a total of 551 participants screened for eligibility, 146 were randomized and 105 were analyzed (mean [SD] age, 66.7 [9.2] years, 71 [67.1%] women), including 48 participants in the intervention group and 57 participants in the control group. There were no significant differences in baseline characteristics between the groups. At the 6-week follow-up, the intervention group showed a greater NRS pain score reduction than the control group (between-group difference, -1.5 [95% CI, -2.2 to -0.8]; P < .001). Similarly, the intervention group had better improvements in the 30-second sit-to-stand test (between-group difference, 3.4 [95% CI, 2.2 to 4.5]; P < .001) and Timed Up-and-Go test (between-group difference, -1.8 [95% CI, -3.0 to -0.5] seconds; P = .007), as well as the WOMAC subscales for pain (between-group difference, -1.1 [95% CI, -2.0 to -0.2]; P = .02), stiffness (between-group difference, -1.0 [95% CI, -1.5 to -0.5]; P < .001), and physical function (between-group difference, -3.4 [95% CI, -6.2 to -0.7]; P = .02). The magnitude of within-group changes in pain (d = 0.83) and function outcomes (30 second sit-to-stand test d = 1.24; Timed Up-and-Go test d = 0.76) in the intervention group corresponded to medium to very strong effects. No adverse events were reported.
These findings suggest that this internet-delivered, evidence-based, first-line osteoarthritis treatment was superior to routine self-managed usual care and could be provided without harm to people with osteoarthritis. Effect sizes observed in the intervention group corresponded to clinically important improvements.
ClinicalTrials.gov Identifier: NCT03545048.
骨关节炎是一种普遍存在、使人衰弱且代价高昂的慢性疾病,其推荐的一线治疗方法未得到充分利用。
比较基于互联网的膝关节骨关节炎治疗与常规自我管理(即常规护理)的效果。
设计、地点和参与者:这项随机临床试验于 2018 年 10 月至 2020 年 3 月进行。参与者包括从现有初级保健数据库或社交媒体广告中招募的年龄在 45 岁及以上、确诊为膝关节骨关节炎的个体。数据于 2020 年 4 月至 7 月进行分析。
干预组和对照组均符合膝关节骨关节炎的一线治疗。对于干预组,通过智能手机应用程序提供治疗。对照组接受常规自我管理护理。
主要结局是与组间比较,从基线到 6 周时自我报告的过去 7 天的疼痛变化,用数字评分量表(NRS;范围 0-10,0 表示无痛,10 表示可想象到的最痛)进行评估。次要结局包括 2 项身体功能评分、腘绳肌和股四头肌力量、西部安大略省和麦克马斯特大学骨关节炎指数(WOMAC)和定量感觉测试。
在总共筛选出的 551 名符合条件的患者中,有 146 名被随机分配,105 名被纳入分析(平均[标准差]年龄 66.7[9.2]岁,71 名[67.1%]为女性),包括干预组的 48 名患者和对照组的 57 名患者。两组在基线特征方面没有显著差异。在 6 周随访时,干预组的 NRS 疼痛评分较对照组下降更明显(组间差异,-1.5[95%CI,-2.2 至-0.8];P<0.001)。同样,干预组在 30 秒坐立测试(组间差异,3.4[95%CI,2.2 至 4.5];P<0.001)和计时起立行走测试(组间差异,-1.8[95%CI,-3.0 至-0.5]秒;P=0.007)以及 WOMAC 疼痛(组间差异,-1.1[95%CI,-2.0 至-0.2];P=0.02)、僵硬(组间差异,-1.0[95%CI,-1.5 至-0.5];P<0.001)和身体功能(组间差异,-3.4[95%CI,-6.2 至-0.7];P=0.02)方面也有更好的改善。干预组中疼痛(d=0.83)和功能结局(30 秒坐立测试 d=1.24;计时起立行走测试 d=0.76)的组内变化幅度对应于中等至非常大的效果。未报告不良事件。
这些发现表明,这种基于互联网的、循证的、一线骨关节炎治疗方法优于常规自我管理的常规护理,并且可以在不伤害骨关节炎患者的情况下提供。干预组中观察到的效应大小与临床上重要的改善相对应。
ClinicalTrials.gov 标识符:NCT03545048。