NCT02151045Unknown3 期
Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Pain evolution on analogic visual scale (EVA) ay Day 30
研究概览
简要总结
In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Aged from 18 to 65 years
- •Affiliated or benefit from an insurance regimen
- •Patient with a sciatic answering to the definition
- •Discal sciatica more than 15 days and less than 6 months
- •Discal hernia (scan or RMI)
- •Negative BHCG and normal coagulation parameters
排除标准
- •History of lumbar surgery
- •Spinal infiltration of corticoids in 30 days before inclusion
- •Iode allergy
- •Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
- •Motor loss < 4 (muscular testing)
- •Sphincter disorder (cauda equida syndrome)
结局指标
主要结局
Pain evolution on analogic visual scale (EVA) ay Day 30
时间窗: at Day 30 after infiltration
次要结局
- Pain evolution on analogic visual scal (EVA) at month 3(at month 3 after infiltration)
- Pain evolution on analogic visual scal (EVA) at month 12(at month 12 after infiltration)
- functional handicap at month 3(at month 3 after infiltration)
- Pain evolution on analogic visual scal (EVA) at month 6(at month 6 after infiltration)
- drug consumption at month 6(at month 6 after infiltration)
- functional handicap at Day 7(at day 7 after infiltration)
- new epidural infiltration or surgery of discal hernia at month 3(at month 3 after infiltration)
- Pain evolution on analogic visual scal (EVA) at Day 7(at day 7 after infiltration)
- professional activity recovery at month 3(at month 3 after infiltration)
- new epidural infiltration or surgery of discal hernia at month 12(at month 12 after infiltration)
- drug consumption at day 7(at day 7 after infiltration)
- drug consumption at month 3(at month 3 after infiltration)
- functional handicap at month 6(at month 6 after infiltration)
- functional handicap at month 12(at month 12 after infiltration)
- professional activity recovery at Day 7(at day 7 after infiltration)
- new epidural infiltration or surgery of discal hernia at month 6(at month 6 after infiltration)
- drug consumption at month 12(at month 12 after infiltration)
- professional activity recovery at month 6(at month 6 after infiltration)
- professional activity recovery at month 12(at month 12 after infiltration)
- new epidural infiltration or surgery of discal hernia at Day 7(at day 7 after infiltration)
研究者
研究点 (4)
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