CTRI/2023/11/059660尚未招募4 期
A randomized comparative study to assess the effectiveness of Methylprdnisolone acetate, Dexamethasone Sodium Phosphate and 5% Dextrose solution through epidural in improvement of pain and function in patient with lumbar radicular pain at Sawai Man Singh medical college, Jaipur.
SMS hospital Jaipur Rajasthan1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年11月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To compare the improvement in pain using VAS
研究概览
简要总结
As the lower back pain is one of the major cause of morbidities, which includes lumbar radicular pain and there is a known good effect of caudal epidural injection with steroids, so we are trying to compare the effect of two steroids (particulate & non particulate steroids) and prolotherapy in improving pain and function using VAS and ODI scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Those willing to give an informed written consent to participate in study.
- •Those clinically diagnosed as having lumbosacral radicular pain.
排除标准
- •Patients presenting with a cauda equina syndrome, severe paresis, severe pain, history of spinal injection or surgery, deformity, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs , or severe comorbidity.
- •Any medical or surgical condition preventing communication and compliance of study protocol eg.
- •Cognitive impairment, TBI, hearing impairment etc.
- •Pregnant / lactating females.
结局指标
主要结局
To compare the improvement in pain using VAS
时间窗: Baseline, 4 weeks, 6 weeks &12 weeks
次要结局
- 1. To compare Quality of life between the group.(2. To study various ethological factors of low back pain.)
研究者
研究点 (1)
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