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
试验速览
- 阶段
- 3 期
- 入组人数
- 112
- 试验地点
- 2
- 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)
研究组 & 干预措施
Non target epidural infiltration at L3-L4 stage
In this control arm, there are patients with a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control.
These patients must have a discal hernia confirmed by scanner or RMI
干预措施: Non target epidural infiltration done at L3-L4 stage (Procedure)
Epidural infiltration on contact of disco radicular conflict
In this experimental arm, there are patients with an epidural infiltration of corticoids done in lateral on contact of disco radicular conflict on scan control.
These patients must have a discal hernia confirmed by scanner or RMI
干预措施: Epidural infiltration on contact of disco radicular conflict (Procedure)
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)