坐式连续被动运动机器在全膝关节置换患者中的实用性和有效性的临床评估：一项双中心随机对照试验。
Clinical evaluation of usefulness and effectiveness of sitting-type continuous passive motion machines in patients with total knee arthroplasty: a dual-center randomized controlled trial.
作者信息
Lee Byung Chan, Moon Chang-Won, Choi Woo Sung, Kim Young Mo, Joo Yong Bum, Lee Da Gyo, Lee Sook Joung, Choi Eunseok, Ji Jong Hun, Suh Dong Whan, Cho Kang Hee
机构信息
Department of Physical Medicine and Rehabilitation, Chung-Ang University College of Medicine, Seoul, Korea.
Department of Rehabilitation Medicine, Chungnam National University College of Medicine, Daejeon, Korea.
出版信息
BMC Musculoskelet Disord. 2024 Dec 19;25(1):1039. doi: 10.1186/s12891-024-08062-0.
BACKGROUND
Total knee arthroplasty (TKA) is a treatment option for osteoarthritis of the knee. After undergoing TKA, patients can be treated with continuous passive motion (CPM); however, inconsistent results have been reported on the effectiveness of CPM as part of a rehabilitation strategy. This discrepancy may be due to the difference between the set-arc of CPM and real arcs of knee motion. In this randomized controlled trial, we compared the efficacy of the sitting-type CPM, which can apply a more fitted arc of motion, to that of the conventional CPM.
METHODS
We performed a prospective, multicenter, single-blind, three-arm, randomized controlled trial. Patients who underwent unilateral TKA were recruited and randomly allocated to three groups (151 participants; Group 1, conventional type; Group 2, mixed; and Group 3, sitting type). All participants underwent 10 days of CPM management. Passive and active ranges of motion (ROMs), pain, lower-extremity edema, patient-reported outcomes, and functional assessments were evaluated at four time points.
RESULTS
Passive and active ROMs and pain significantly improved during and after the intervention in all groups; however, no significant differences were noted between the groups. Compared with the conventional type, the sitting-type CPM devices were rated higher in participant's satisfaction questionnaires.
CONCLUSION
The sitting-type CPM had equivalent efficacy to that of the conventional-type CPM but provided higher satisfaction to patients after TKA. Therefore, the sitting-type CPM may be a useful tool in post-TKA rehabilitation.
CLINICAL TRIAL REGISTRATION
This clincial trial was registed with the Clinical Research Information Service of Republic of Korea, KCT0005520, Registered on 21 October 2020, date of first enrollment at 10/11/2020 https://cris.nih.go.kr/cris/search/detailSearch.do/21750 .
背景
全膝关节置换术（TKA）是膝关节骨关节炎的一种治疗选择。接受TKA手术后，患者可接受持续被动运动（CPM）治疗；然而，关于CPM作为康复策略一部分的有效性，报告结果并不一致。这种差异可能是由于CPM设定的活动弧度与膝关节实际活动弧度之间的差异。在这项随机对照试验中，我们比较了能应用更贴合活动弧度的坐式CPM与传统CPM的疗效。
方法
我们进行了一项前瞻性、多中心、单盲、三臂随机对照试验。招募接受单侧TKA的患者，并随机分为三组（151名参与者；第1组为传统型；第2组为混合型；第3组为坐式）。所有参与者均接受为期10天的CPM管理。在四个时间点评估被动和主动活动范围（ROM）、疼痛、下肢水肿、患者报告的结果和功能评估。
结果
所有组在干预期间和干预后，被动和主动ROM以及疼痛均有显著改善；然而，各组之间未观察到显著差异。与传统型相比，坐式CPM设备在参与者满意度问卷中的评分更高。
结论
坐式CPM与传统型CPM疗效相当，但在TKA术后能为患者提供更高的满意度。因此，坐式CPM可能是TKA术后康复的一种有用工具。
临床试验注册
本临床试验在大韩民国临床研究信息服务中心注册，注册号为KCT0005520，于2020年10月21日注册，首次入组日期为2020年11月10日，网址为https://cris.nih.go.kr/cris/search/detailSearch.do/21750 。
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