A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
研究概览
简要总结
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lumbosacral spinal stenosis with radiculopathy
- •no improvement after conservative treatment for 6 weeks
排除标准
- •previous CESI or spinal surgery
- •skin infection at injection site
- •uncontrolled diabetes mellitus
- •abnormal coagulogram
- •vertebral fracture
- •previous history of allergy to steroid or anesthetic agent
研究组 & 干预措施
Group 1: 40 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
干预措施: Triamcinolone Acetonide and normal saline solution (Drug)
Group 2: 20 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min
干预措施: Triamcinolone Acetonide and normal saline solution (Drug)
结局指标
主要结局
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
时间窗: 2, 6, 12 weeks
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
时间窗: 2, 6, 12 weeks
Change from baseline Standing tolerance test at 2, 6, 12 weeks
时间窗: 2, 6, 12 weeks
Change from baseline Walking tolerance test at 2, 6, 12 weeks
时间窗: 2, 6, 12 weeks
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
时间窗: 2, 6, 12 weeks
次要结局
- Complication of Caudal Epidural Steroid Injection(2, 6, 12 weeks)
研究者
Satit Thiengwittayaporn
Associate Professor
Navamindradhiraj University