To compare the analgesic efficacy of a single Lateral Recess steroid injection vs single Caudal epidural steroid injection in Lumbar disc prolapse patients with predominantly unilateral symptoms A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare Improvement in the two groups receiving the interventions on the Oswestry Disability Index (ODI)
研究概览
简要总结
This study is a prospective, randomized, double-blind controlled trial conducted at AIIMS Bhopal to compare the analgesic efficacy of lateral recess steroid injection (LRSI) and caudal epidural steroid injection (CESI) in patients with lumbar disc prolapse presenting predominantly with unilateral symptoms. A total of 100 adults aged 18–60 years, with MRI-confirmed L4–L5 or L5–S1 disc herniation and unilateral radicular pain persisting for more than three months despite at least six weeks of conservative therapy, will be enrolled. Patients with prior lumbar surgery, severe neurological deficits, cauda equina, uncontrolled systemic illness, pregnancy, or steroid allergy are excluded. Participants will be randomized into two groups: the LRSI group receiving triamcinolone 40 mg with 0.5–1 ml of 0.125% bupivacaine (total 2–3 ml), and the CESI group receiving triamcinolone 40 mg with 10 ml of 0.125% bupivacaine (total 10 ml), both under fluoroscopic guidance. The primary outcome is improvement in disability assessed by the Oswestry Disability Index (ODI). Secondary outcomes include six-minute walk distance recorded weekly via a mobile app, SF-12 quality-of-life scores, and time to recurrence of pre-procedure symptoms. Patients will be followed up at baseline, one month, and three months. The trial aims to generate high-quality evidence to guide clinicians in selecting the most effective interventional strategy for unilateral lumbar disc prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Adults aged between 18 and 60 years.
- •Clinical Presentation: Unilateral radicular pain corresponding to a specific nerve root distribution, persisting for more than 3 months.
- •Imaging Confirmation: MRI evidence of lumbar disc herniation at L4-L5 or L5-S1 levels, causing nerve root compression.
- •Treatment History: Symptoms refractory to at least 6 weeks of conservative management, including physical therapy and pharmacological treatment.
- •Functional Status: Baseline Oswestry Disability Index (ODI) score indicating moderate to severe disability.
排除标准
- •Previous Lumbar Surgery: History of lumbar spine surgery at the affected level.
- •Neurological Deficits: Presence of severe motor weakness, rapidly progressing neurological symptoms, or signs of cauda equina syndrome.
- •Systemic Conditions: Uncontrolled diabetes mellitus, bleeding disorders, or active infections.
- •Medication Use: Use of systemic corticosteroids within the past 3 weeks.
- •Allergies: Known hypersensitivity to steroids, local anaesthetics, or contrast agents used in the procedures.
- •Pregnancy: Pregnant or lactating women.
- •Other Spinal Pathologies: Presence of spinal tumors, infections, or other non-discogenic causes of radiculopathy.
结局指标
主要结局
To compare Improvement in the two groups receiving the interventions on the Oswestry Disability Index (ODI)
时间窗: At baseline, 4 weeks and 12 weeks
次要结局
- Improvement in 6 Minute Walk distance at weekly interval for 3month after the procedure using a mobile app(At baseline, 1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week, 9 week, 10 week, 11 week, 12 week interval)
- Improvement in quality of life using Short Form Health Survey (SF-12) score.(At baseline, 4 week & 12 week interval)
研究者
Nikhil Nair
AIIMS, Bhopal