CTRI/2018/05/014227招募中2 期
A comparitive study of intraarticular injection of steroid vs prolotherapy for pain relief in patients of osteoarthritis knee
Shashank Kumar1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年2月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- VAS score for pain assessment
研究概览
简要总结
This prospective randomised single blinded study is to compare pain relief with intraarticular injection of triamcinolone acetonide (steroid) with prolotherapy (25% dextrose) in knee. The patients will be divided into two groups. Group A will be given steroid and group B will be given 25% dextrose intraarticularly in knee. The primary outcome measured will be Visual Analogue Scale at 0 hours to 6 months at monthly interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Knee osteoarthritis grade I, II and III Patients with VAS > 5 Platelet count < 1.5 lakh.
排除标准
- •Patients giving negative consent.
- •Inflammatory arthritis.
- •History of recent surgery or intraarticular injection of steroid or hyaluronic acid in last 3 months.
- •Patients on active anticoagulant therapy.
- •Liver or haematological/coagulation disorders.
- •Active local site infection/malignancy.
结局指标
主要结局
VAS score for pain assessment
时间窗: At 0, 1 week, 1, 2, 3, 4, 5, 6 months
Quality of life by Mc gill questionarre, dose of rescue analgesia, repetition of doses of rescue analgesia
时间窗: At 0, 1 week, 1, 2, 3, 4, 5, 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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