Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- lower limbs pain
研究概览
简要总结
An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.
详细描述
An open-label randomized trial conducted in one centre to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica. 30 male and female patients will be included in each group. The primary outcome measure will be a 30% decrease in lower limbs pain as assessed by a visual analog scale.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radicular pain (sciatica or cruralgia) for more than 2 weeks
- •failure of analgesics and NSAIDs
- •without neurological deficiency (motor weakness lower or equal to 3/5)
- •a lumbar disk herniation on MRI or CT dating less than 3 months
排除标准
- •history of lumbar surgery
- •history of epidural injection during the last 3 months
- •radicular pain not due to disk herniation
- •a contraindication to epidural injection (infection, diabetes)
- •history of allergic reaction to corticosteroid
- •patient under legal guardianship
研究组 & 干预措施
ultrasound-guided
ultrasound-guided caudal epidural corticosteroid injection
干预措施: ultrasound-guided (Procedure)
interlaminar
interlaminar epidural corticosteroid injection
干预措施: interlaminar (Procedure)
结局指标
主要结局
lower limbs pain
时间窗: day 15
a 30% decrease in lower limbs pain using a visual analog scale
次要结局
- Oswestry questionnaire(day 15 - month 1 - month 3 - month 6)
- medical outcome(day 15 - month 1 - month 3 - month 6)
- resumption of work(day 15 - month 1 - month 3 - month 6)
- A decrease of radicular pain with a pain numerical scale lower or equal to 3/10(day 15 - month 1 - month 3 - month 6)
- neurological deficiency assessed by neurological examination(day 15 - month 1 - month 3 - month 6)
- drugs(day 15 - month 1 - month 3 - month 6)
- number of patients with treatment-related adverse events as assessed by CTCAE v4.0(day 15 - month 1 - month 3 - month 6)