SciaticaLow Back PainLumbar Spinal StenosisRadiculopathyLumbar Disc Herniation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older
* Presence of clinical and radiological radiculopathy findings consistent with L4, L5, or S1 nerve root involvement
* Symptoms present for at least 3 months
* Resistant to conservative treatment
* Scheduled for transforaminal epidural steroid injection (TFESI) by a pain medicine specialist
* Being willing to participate in the study and having signed a consent form
Exclusion Criteria:
* Malignancy
* Coagulation disorders
* Pregnancy
* History of allergic reaction to the injected substances
* History of major psychiatric disorders
* Presence of known coagulopathy
* Receiving systemic steroid treatment for any reason
* Having received an epidural steroid injection within the last 3 months
Primary outcome measure(s)
Change in pain intensity measured by Numeric Rating Scale (NRS) — Baseline, 1 hour, 3 months, 6 months after TFESI Pain intensity will be assessed using the Numeric Rating Scale (0-10). A reduction of ≥50% from baseline will be considered a positive treatment response.
Change in functional status measured by Oswestry Disability Index (ODI) — Baseline, 3 months, 6 months Functional disability will be assessed using the validated ODI questionnaire.
Trial sites (1)
Facility
City
Region
Status
Marmara Üniversitesi Tıp Fakültesi, İstanbul , Maltepe 34854 Recruiting
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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