NCT00435773已完成2 期
Single and Repeated Leech Therapy for the Treatment of Late Stage Knee Osteoarthritis. A Randomized, Placebo Controlled Comparative Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
研究概览
简要总结
Previous studies have not addressed the question, whether or not a repeated leeching can supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a randomized study to the effectiveness of single and repeated leech therapy in cases with advanced osteoarthritis of the knee using a large patient group compared to a control group, who were both blinded to the actual treatment modality.
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee
- •Persistent osteoarthritic symptoms for at least 6 months
- •Radiographic evidence of late stage osteoarthritis of the knee (stage III-IV)
- •History of conservative management including pain medication and physical therapy
排除标准
- •Anticoagulant treatment or history of hemophilia
- •History or presence of rheumatic diseases leading to secondary osteoarthritis
- •Presence of hematological, hepatic, renal or immunological disease
- •Insulin-dependant diabetes mellitus
- •Intraarticular injections or systemic application of corticosteroids during the 3 preceding months
- •History of surgery of the affected knee during the last 3 months or joint replacement
- •History of previous leech therapy
- •Lack of informed consent
结局指标
主要结局
KOOS Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
WOMAC Score overall (Clinical score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
VAS (Visual analog scale, pain score)before intervention, after 1,4 and 6 weeks, 3 and 6 months
次要结局
- KOOS subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
- WOMAC subscores before intervention, after 1,4 and 6 weeks, 3 and 6 months
- Requirement of pain medication before intervention, after 1,4 and 6 weeks, 3 and 6 months
- Adverse events
研究者
研究点 (2)
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