Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain intensity measured by Visual Analogue Scale (VAS)
研究概览
简要总结
This study compares caudal and transforaminal epidural steroid injections for treating unilateral S1 nerve root pain. It evaluates pain relief, functional improvement, treatment satisfaction, quality of life, and complications over 12 months.
详细描述
Unilateral S1 nerve root pain is a common manifestation of lumbosacral radiculopathy and may persist despite conservative treatment. Epidural steroid injections are used as an interventional treatment option for patients with persistent radicular pain. Different approaches to epidural steroid delivery may produce different patterns of pain relief and functional improvement, but their comparative clinical effectiveness in patients with unilateral S1 nerve root pain remains an important clinical question.
This randomized controlled trial was designed to compare two approaches to epidural steroid administration: caudal epidural steroid injection and transforaminal epidural steroid injection. The study focuses on patients with unilateral S1 nerve root pain associated with imaging-confirmed nerve root compression who have persistent symptoms despite conservative management.
The principal purpose of the study is to characterize and compare the clinical response associated with the two injection approaches over an extended follow-up period. The study evaluates changes in pain and functional status together with patient-reported quality of life and satisfaction with treatment. The study also considers the duration and sustainability of treatment effects and documents treatment-related complications and adverse events.
The comparison is intended to provide clinical information regarding the relative effectiveness and safety of the two epidural injection approaches in the management of unilateral S1 nerve root pain. Assessment across multiple follow-up points allows the study to examine both the early response following treatment and the persistence of clinical effects over time.
The study uses a parallel-group randomized controlled design in which eligible participants are allocated to receive either caudal or transforaminal epidural steroid injection. The study procedures, eligibility criteria, outcome measures, follow-up schedule, and statistical methods are described in their respective sections of the clinical trial record.
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 (Participant)
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
- •Age 18-75 years.
- •Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.
- •Pain duration > 6 weeks despite conservative therapy.
排除标准
- •Previous epidural steroid injection in the past 6 months.
- •Significant neurological deficits requiring immediate surgery.
- •Coagulopathy or current anticoagulant therapy.
- •Allergy to corticosteroids or contrast agents.
研究组 & 干预措施
Group A: Caudal Epidural Steroid Injection (CEI)
Participants receive a caudal epidural steroid injection through the sacral hiatus under fluoroscopic guidance. A corticosteroid combined with a local anesthetic is administered into the epidural space, with contrast dye used to confirm proper needle placement and epidural distribution.
干预措施: Caudal Epidural Steroid Injection (CEI) (Procedure)
Group B: Transforaminal Epidural Steroid Injection (TFI)
Participants receive a transforaminal epidural steroid injection targeting the affected S1 neural foramen under fluoroscopic guidance. A corticosteroid and local anesthetic mixture is administered, with contrast dye used to confirm proper epidural distribution.
干预措施: Transforaminal Epidural Steroid Injection (TFI) (Procedure)
结局指标
主要结局
Pain intensity measured by Visual Analogue Scale (VAS)
时间窗: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention
Pain intensity will be assessed using the Visual Analogue Scale (VAS) to compare pain relief between caudal epidural steroid injection and transforaminal epidural steroid injection groups.
次要结局
- Change in Functional Outcome Over 12 Months(Baseline, 1 month, 3 months, 6 months, and 12 months after intervention)
- Oswestry Disability Index (ODI)(Baseline, 1 month, 3 months, 6 months, and 12 months after intervention)
- Health-Related Quality of Life measured by SF-36(Baseline, 1 month, 3 months, 6 months, and 12 months after intervention)
- Duration of Pain Relief(From 1 week through 12 months after intervention)
- Procedure-Related Complications(From intervention through 12 months after intervention)
研究者
Ahmad
PGR
University of Health Sciences Lahore