Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc：A Single Center, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Pain Assessed by Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.
详细描述
One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of herniated lumbar disc
- •written informed consent obtained
排除标准
- •Lumbar instability
- •Piriformis syndrome
- •Diabetes mellitus with uncontrolled blood glucose
- •Severe osteoporosis
- •Impaired function of cauda equina
- •Severe sacral hiatus variation
- •Interspinous ligament inflammation
- •Myofascitis on lumbar and legs
- •The third lumbar transverse process syndrome
研究组 & 干预措施
Epidural neuroplasty group
This group will be given epidural neuroplasty once enrolled.
干预措施: Mechanical epidural neuroplasty (Device)
Epidural neuroplasty group
This group will be given epidural neuroplasty once enrolled.
干预措施: Caudal epidural compound betamethasone injection (Drug)
Epidural neuroplasty group
This group will be given epidural neuroplasty once enrolled.
干预措施: Epidural hyaluronidase injection (Drug)
Transforaminal steroid injection group
This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.
干预措施: Transforaminal epidural compound betamethasone injection (Drug)
结局指标
主要结局
Pain Assessed by Visual Analogue Scale
时间窗: at six-month post-treatment
VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
次要结局
- Functional Status Assessed by Oswestry Disability Index(at six-month post-treatment)
研究者
yan lu
Director of the pain clinic of Xijing Hospital
Xijing Hospital