Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sciatica, Low Back Pain, Lumbar Spinal Stenosis, Radiculopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence-Based Predictive Models for Estimating Treatment Response in Sciatica Patients Treated With Transforaminal Epidural Steroid Injection (TFESI)
Overview
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.
Primary outcome measures
- Change in pain intensity measured by Numeric Rating Scale (NRS) [Time frame: Baseline, 1 hour, 3 months, 6 months after TFESI]
- Change in functional status measured by Oswestry Disability Index (ODI) [Time frame: Baseline, 3 months, 6 months]
Secondary outcome measures (2)
- Change in psychological status measured by Beck Depression Inventory (BDI) [Time frame: Depression symptoms will be evaluated using BDI to assess changes related to pain improvement.]
- Change in health-related quality of life measured by SF-12 [Time frame: Baseline, 3 months and 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Marmara Üniversitesi Tıp Fakültesi, İstanbul , Maltepe 34854 Recruiting — Istanbul
Identifiers
NCT: NCT07080307 · MAR.FTR.FK.01