About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Malignancy
Coagulation disorders
Pregnancy
History of allergic reaction to the injected substances
Trial population
Participants will be recruited from the Algology Clinic of Marmara University Pendik Training and Research Hospital. The population includes patients who have been referred for transforaminal epidural steroid injection (TFESI) as part of routine clinical care for sciatica. Data will be collected prospectively during their treatment and follow-up visits.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in pain intensity measured by Numeric Rating Scale (NRS)
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)
Functional disability will be assessed using the validated ODI questionnaire.
Secondary outcomes
Change in psychological status measured by Beck Depression Inventory (BDI)
Baseline, 3months and 6 months
Change in health-related quality of life measured by SF-12
SF-12 will be used to assess the impact of pain and treatment on quality of life.
Sponsors and contacts
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