Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.
研究概览
简要总结
Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.
详细描述
Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.
Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.
200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
- •Patients more than 18 years old
排除标准
- •Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
- •Patients with cauda equina syndrome who needed acute operative treatment
- •Lack of informed consent and inability to read and understand Danish
研究组 & 干预措施
Epidural steroid
1.0 mL methylprednisolone acetate 40 mg/mL instilled at the decompressed nerve root
干预措施: Methylprednisolone (Drug)
None epidural steroid
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.
时间窗: 2 years
次要结局
- Hospital stay, back and leg pain and reflex deficit.(2 years)