Health TrialsbyHealthPanel

Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial

ConditionUnilateral S1 Nerve Root Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years.

Clinical symptoms and MRI confirmation of unilateral S1 nerve root compression.

Pain duration > 6 weeks despite conservative therapy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caudal Epidural Steroid Injection (CEI)

    Procedure/Surgery

    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.

  • Transforaminal Epidural Steroid Injection (TFI)

    Procedure/Surgery

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group A: Caudal Epidural Steroid Injection (CEI)Active comparator 1 intervention
Group B: Group B: Transforaminal Epidural Steroid Injection (TFI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Health Sciences Lahore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: