Clinical Trial

Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection

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Record status
This record was last updated July 23, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
This prospective observational study aims to develop artificial intelligence (AI)-based predictive models to estimate treatment response in patients with sciatica undergoing transforaminal epidural steroid injection (TFESI). Approximately 1500 adult patients diagnosed with sciatica and scheduled for TFESI at Marmara University Training and Research Hospital Algology Clinic will be enrolled. Clinical, radiological, laboratory, and psychological data will be systematically collected before the procedure and at multiple follow-up points (1 hour, 3 weeks, 3 months, and 6 months post-treatment). Pain relief, measured by a 50% or greater reduction in the Numeric Rating Scale (NRS), will be the primary outcome. The study will use these comprehensive data sets to train and validate AI algorithms, aiming to create a decision-support system that can predict individual patient responses to TFESI and improve personalized treatment planning.
Trial Details
NCT Number NCT07080307
Lead Sponsor Marmara University
Conditions Sciatica, Low Back Pain, Lumbar Spinal Stenosis, Radiculopathy, Lumbar Disc Herniation
Enrollment 1,500 participants
Start Date 2025-07
Primary Completion 2026-04 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-07-23