The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline in knee pain severity after 2 months.
研究概览
简要总结
Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.
详细描述
Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic medial femorotibial knee OA,
- •Daily knee pain for at least 1 month in the last 3 months,
- •Radiographic evidence of medial femorotibial knee OA,
- •Normal erythrocyte sedimentation rate.
排除标准
- •Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography,
- •Knee joint lavage in past 3 months,
- •Intra-articular corticosteroid injection during the past 3 months,
- •Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.
结局指标
主要结局
Change from baseline in knee pain severity after 2 months.
时间窗: Up to 2 months
The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.
次要结局
- Change from baseline in knee's functional degree after 2 months.(Up to 2 months.)
研究者
Farnaz Dehgan Hosseinabadi
Dr.
Isfahan University of Medical Sciences