NCT01205477已完成2 期
Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Universidad Autonoma de Nuevo Leon1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- WOMAC score
研究概览
简要总结
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of anserine bursitis
排除标准
- •Intraarticular pathology that reflects pain in the medial part of the knee
研究组 & 干预措施
Methylprednisolone
Experimental
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine
干预措施: EXPERIMENTAL (Drug)
Placebo
Placebo Comparator
Infiltration of 1 mL of xylocaine
干预措施: PLACEBO (Drug)
结局指标
主要结局
WOMAC score
时间窗: 4 weeks
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. Pain, Stiffness and Physical functionVisual analogue scale (VAS) may be used ranging from 0 to 10.
次要结局
- VAS satisfaction(4 weeks)
- Improvement(4 weeks)
- SAFETY(4 weeks)
研究者
研究点 (1)
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