Sydney Musculoskeletal Health, Kolling Institute, the University of Sydney, Sydney, New South Wales, Australia.
Northern Sydney Local Health District, Royal North Shore Hospital, Sydney, New South Wales, Australia.
JAMA Netw Open. 2023 Sep 5;6(9):e2333172. doi: 10.1001/jamanetworkopen.2023.33172.
Digital technology represents an opportunity to improve outcomes following total knee replacement (TKR). Digitally delivered interventions have been shown to be similar to face-to-face interventions and to increase participation levels in people with osteoarthritis.
To assess the effect of a digital technology package in reducing pain compared with usual care following TKR.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial recruited 102 adults after they received TKR in 3 rehabilitation hospitals in Sydney, Australia, between June 2020 and July 2021.
All participants underwent usual care. In addition to usual care, 51 participants received a digital technology package consisting of an exercise app, fitness tracker, and online health coaching. In the usual care group, 51 participants received a fitness tracker but with all notifications turned off and goals for step count, sleep, and active hours removed. Participants were followed up for 12 months (June 2021 to July 2022).
The primary outcome was mean knee pain during the past week assessed using a numerical rating scale (range, 0-10, with 10 indicating worst possible pain) at 3 months. In unadjusted analyses, considered primary and based on multiple imputations, independent t tests were used to compare means between groups. Secondary outcomes, including measures of function, activity participation, and quality of life, were analyzed using a generalized estimating equation model that accounted for repeated measurements.
Of 102 participants (mean [SD] age, 67.9 [7.2] years; 68 [67%] female; and 92 [90%] White) randomly assigned to intervention or usual care groups, 47 (92%) in each group completed the 3-month follow up. At 3 months, participants in the intervention group demonstrated small but not clinically meaningful improvements in pain compared with the usual care group in the unadjusted intention-to-treat analysis (mean difference, -0.84; 95% CI, -1.59 to -0.10; P = .03). Secondary outcomes indicated a statistically significant reduction in pain intensity, (mean difference, -0.94; 95% CI, -1.82 to -0.06), pain disability (mean difference, -5.42; 95% CI, -10.00 to -0.83), and sedentary behavior (mean difference, -9.76; 95% CI, -19.17 to -0.34) favoring the intervention from baseline to 3, 6, and 12 months.
In this randomized clinical trial, a combined digital technology program provided small but not clinically meaningful improvements in pain at 3 months and other longer-term favorable outcomes following TKR compared with usual care. Future studies should tailor digital interventions based on participants' abilities and preferences to ensure that the intervention is appropriate and fosters long-term self-management.
Anzctr.org.au Identifier: ACTRN12618001448235.
数字技术为全膝关节置换（TKR）后的结果改善提供了机会。已经证明，数字化干预与面对面干预相似，并增加了骨关节炎患者的参与度。
评估数字技术包在 TKR 后与常规护理相比在减轻疼痛方面的效果。
设计、地点和参与者：本随机临床试验招募了 2020 年 6 月至 2021 年 7 月期间在澳大利亚悉尼的 3 家康复医院接受 TKR 的 102 名成年人。
所有参与者均接受常规护理。除常规护理外，51 名参与者还接受了包含运动应用程序、健身追踪器和在线健康教练的数字技术包。在常规护理组中，51 名参与者收到了一个健身追踪器，但所有通知都关闭了，并且删除了步数、睡眠和活跃时间的目标。参与者在 12 个月内（2021 年 6 月至 2022 年 7 月）接受随访。
主要结局是使用数字评分量表（范围 0-10，10 表示最严重的疼痛）评估过去一周的平均膝关节疼痛，在 3 个月时进行评估。在未调整的分析中，基于多重插补，认为主要和次要结果是基于独立 t 检验比较组间平均值。次要结局，包括功能、活动参与和生活质量测量，使用考虑到重复测量的广义估计方程模型进行分析。
在随机分配到干预或常规护理组的 102 名参与者（平均[SD]年龄 67.9[7.2]岁；68[67%]女性；92[90%]为白人）中，每组有 47 名（92%）完成了 3 个月的随访。在未调整的意向治疗分析中，与常规护理组相比，干预组在 3 个月时的疼痛在无统计学意义的情况下略有改善（平均差异-0.84；95%CI，-1.59 至-0.10；P=0.03）。次要结局表明疼痛强度（平均差异-0.94；95%CI，-1.82 至-0.06）、疼痛残疾（平均差异-5.42；95%CI，-10.00 至-0.83）和久坐行为（平均差异-9.76；95%CI，-19.17 至-0.34）均有统计学意义的降低，从基线到 3、6 和 12 个月均有利于干预。
在这项随机临床试验中，与常规护理相比，在 TKR 后 3 个月和其他长期有利结局方面，综合数字技术方案提供了微小但无临床意义的疼痛改善。未来的研究应根据参与者的能力和偏好调整数字干预措施，以确保干预措施合适并促进长期自我管理。
Anzctr.org.au Identifier：ACTRN12618001448235。
