Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Pain intensity measured by Visual Analogue Scale (VAS)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years.
- •Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.
- •Pain duration > 6 weeks despite conservative therapy.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: Transforaminal Epidural Steroid Injection (TFI) (Procedure)
Outcomes
Primary Outcomes
Pain intensity measured by Visual Analogue Scale (VAS)
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Ahmad
PGR
University of Health Sciences Lahore