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临床试验/NCT02443974
NCT02443974已完成4 期

Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Change in pain measured by a numeric pain scale

研究概览

简要总结

Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pain in numerical pain scale between 3 and 7cm;
  • Knee ligamentous instability

排除标准

  • fibromyalgia and neurologic disease;
  • knee or hip replacement
  • surgery scheduled in the following 6 months
  • start physical activity or received joint injection in the past three months
  • need to use walking aids or brace in knee

结局指标

主要结局

Change in pain measured by a numeric pain scale

时间窗: Baseline, after 45, 90 and 180 days

次要结局

  • Change in function measured by Lequesne and WOMAC questionnaires(Baseline, after 45, 90 and 180 days)
  • Change in quality of life measured by SF-36 questionnaire(Baseline, after 45, 90 and 180 days)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Brumini

MsC

Federal University of São Paulo

研究点 (2)

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