Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in pain severity
研究概览
简要总结
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old
详细描述
Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline
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
- Single (Outcomes Assessor)
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
- •Age between 18 and 65 years
- •Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
- •Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
- •Having low back and leg pain for at least six months and unresponsive to conservative therapies
- •A Numerical Rating Scale score of ≥4
- •Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging
排除标准
- •Having a multi-level epidural fibrosis
- •Previous surgery for multi-level disc herniation
- •Previous lumbar fusion surgery
- •Having recurrent disc hernia
- •Having sacroiliac/facet joint pain
- •Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis
- •History of epidural steroid injection within the past six months
- •Having bleeding diathesis
- •Presence of systemic or local infections
- •Pregnancy
- •Known hypersensitivity to the injectates to be applied
结局指标
主要结局
Change in pain severity
时间窗: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).
Change in disability score
时间窗: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.
次要结局
未报告次要终点