Effectiveness of intra-articular Ozone therapy on quality of life and knee function compared with intra articular steroid in patients with primary osteoarthritis of knee : A Randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Quality of Life in terms of SF-36 score
研究概览
简要总结
This study is a randomized, parallel group, active controll trial comparing the effectiveness of intra articular injection of Ozone 10ml in quality of life and knee function with intra articular injection of methyl prednisolone 80 mg(2ml) in 54 patients with Primary osteoarthritis of knee that will be conducted in Department of Physical Medicine and Rehabilitation , Regional Institute of Medical sciences, imphal, manipur in India. The primary outcome measures will be Quality of Life in terms of SF-36 score at 12 weeks and Knee function in terms of WOMAC Index at 12 weeks. The secondary outcomes will be Quality of Life in terms of SF-36 score at 1 week, 4 weeks and Knee function in terms of WOMAC Index at 1 week , 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with symptom duration more than 3 months Patient with Kellgren-Lawrence Grade 2 or 3 Patients who give willingness to participate and comply with treatment and follow up.
排除标准
- •Recent knee trauma or knee surgery Any other knee disease or infection Metabolic disease of bone Cognitive impairment Uncontrolled systemic disease Bleeding disorders Recent myocardial infarction or stroke Intra articular steroid injection during past 3 months.
结局指标
主要结局
Quality of Life in terms of SF-36 score
时间窗: 1 Week, 4 Weeks, 12 Weeks
次要结局
- Knee function in terms of WOMAC index(1 week, 4 weeks, 12 weeks)