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临床试验/NCT04136431
NCT04136431已完成不适用

The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Chang Gung Memorial Hospital0 个研究点目标入组 60 人开始时间: 2012年3月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Numeric Rating Scale (NRS)

研究概览

简要总结

The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.

详细描述

The International Association for the Study of Pain (IASP) has proposed the definition of pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Therefore, adequate pain management and control of localized swelling and stiffness after TKA has become a priority because it is essential for improving patient satisfaction, prevention of complications, and enhancing quality of life by faster recovery. Systemic and local analgesics are the most common strategies for postoperative pain management in TKR. However, patients might experience nausea, vomiting, constipation, or respiratory failure due to opioid-related side effects, subsequently refusing to mobilize and delaying the rehabilitation program).

In addition to pain control, cryotherapy and continuous passive motion (CPM) are commonly used for TKA patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion. The application of cryotherapy after TKA has been described extensively in the literature and is part of standard care globally. However, its benefits and value remain controversial due to the disparity in practice, such as differences in clinical protocols and the type of cryotherapy application. Continuous passive motion is a motorized device, which passively moves the knee joint within a certain range of motion (ROM) to decrease analgesics requirements, reduce the incidence of deep vein thrombosis, and increase ROM. But the effects of CPM remain contentious in the literature. Although controversial, cryotherapy and CPM have been used extensively as part of the standard postoperative management protocol for TKA patients without knowing its cost-effectiveness. However, the value of combined therapy of cryotherapy and CPM remains uncertainty and unclear following CAS-TKA.

The hypothesis of this study was the patients, who received programed cryotherapy and CPM, had experienced less postoperative pain, joint swelling, and increased ROM following CAS-TKA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •primary and unilateral computer-assisted total knee arthroplasty

排除标准

  • •(1) patients who underwent bilateral TKAs, unicompartmental TKA or revision TKA
  • •(2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy
  • •(3) patients who were unable to response to the questionnaires.

研究组 & 干预措施

Intervention group

Experimental

干预措施: Programed cryotherapy and continuous passive motion (Other)

Control group

Placebo Comparator

干预措施: Unrogramed cryotherapy and continuous passive motion (Other)

结局指标

主要结局

Numeric Rating Scale (NRS)

时间窗: Postoperative day 4

Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain

Numeric Rating Scale (NRS)

时间窗: Postoperative day 1

Pain score. The scale is 0-10 where 0 is no pain and 10 is the worst pain

次要结局

  • Thigh and calf circumference(Postoperative day 4)
  • Range of motion of knee joints(Postoperative day 4)
  • The short-form McGill Pain Questionnaire (SF-MPQ)(Postoperative day 4)
  • Range of motion of knee joints(Postoperative day 1)
  • The short-form McGill Pain Questionnaire (SF-MPQ)(Postoperative day 1)
  • Thigh and calf circumference(Postoperative day 1)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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