NCT01942317Unknown不适用
The Role of Balneotherapy in Obese Patients With Knee Osteoarthritis
University of Padova2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Knee pain measurement with Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of the study is to evaluate the role of balneotherapy in obese patients with knee osteoarthritis in terms of pain relief, improving joint function and deambulation, on endocrinological parameters, quality of life and of reduction the costs to "Servizio Sanitario Nazionale" (NHS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obesity II-III grade (BMI 35-45 kg/m2)
- •knee pain
- •patient compliance to the treatment
排除标准
- •BMI<34,9kg/m2 or BMI> 45,1kg/m2
- •previous knee surgery
- •complicated diabetes mellitus
- •ischemic cardiomyopathy and heart failure
- •acute phase of osteoarthritis
- •varicose veins, deep venous thrombosis (DVT)
- •cutaneous lesions
- •NSAIDs administration <1 week before the treatment
- •knee infiltration <2 months before the treatment
结局指标
主要结局
Knee pain measurement with Visual Analogue Scale (VAS)
时间窗: At the begining and at the end of the treatment. After 6 months of the end of therapy
次要结局
- Knee range of motion(At the begining and at the end of the treatment. After 6 months of the end of therapy)
研究者
Stefano Masiero
Professore Ordinario
University of Padova
研究点 (2)
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