An interventional study of Caudal Epidural Steroid Injection (CEI) and Transforaminal Epidural Steroid Injection (TFI) in Unilateral S1 Nerve Root Pain, sponsored by University of Health Sciences Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
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.
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Caudal Epidural Steroid Injection (CEI)
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.
Procedure: Transforaminal Epidural Steroid Injection (TFI)
A caudal epidural steroid injection is administered through the sacral hiatus into the epidural space under fluoroscopic guidance. Corticosteroid combined with a local anesthetic is administered, and contrast dye is used to confirm proper needle placement.
A transforaminal epidural steroid injection is administered into the affected S1 neural foramen under fluoroscopic guidance. A steroid and local anesthetic mixture is administered, with contrast dye used to confirm proper epidural distribution.
Pain intensity measured by Visual Analogue Scale (VAS)
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.
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after intervention
Oswestry Disability Index (ODI)
Functional disability will be assessed using the Oswestry Disability Index (ODI) to compare functional outcomes between the caudal epidural steroid injection and transforaminal epidural steroid injection groups.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Health-Related Quality of Life measured by SF-36
Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire to compare quality-of-life outcomes between the two treatment groups.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Duration of Pain Relief
The duration and sustainability of pain relief following epidural steroid injection will be assessed and compared between the two treatment groups.
Time frame: From 1 week through 12 months after intervention
Procedure-Related Complications
Procedure-related complications will be recorded and compared between participants receiving caudal and transforaminal epidural steroid injections.
Time frame: From intervention through 12 months after intervention
Change in Functional Outcome Over 12 Months
Changes in functional status over the follow-up period will be assessed using the Oswestry Disability Index (ODI) and compared between the two treatment groups.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Plan to share: No
Start is estimated for Jan 2027; primary completion for Feb 2028, 12 months later.
Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 12 months is close to that.
Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore