NCT01739296已完成不适用
Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Symptoms
研究概览
简要总结
This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.
详细描述
The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the American College of Rheumatology criteria for knee Osteoarthritis
- •Varus malalignment of the knee
- •Absence of previous fracture on the index knee
- •Absence of previous surgery on the index knee
- •Absence of Rheumatoid Arthritis
- •No Intra-articular injection on the index knee in the past 6 months
- •Receiving usual care for Osteoarthritis for at least 6 months
- •Be able to understand and agree with the informed consent
排除标准
- •Undergo surgery during the study
- •Undergo Intra-articular injection during the study
- •Develop articular infection of the index joint during the study
结局指标
主要结局
Symptoms
时间窗: 24 weeks
Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires
次要结局
- Ankle pain(24 weeks)
研究者
研究点 (2)
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