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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sciatica Low Back Pain Lumbar Spinal Stenosis Radiculopathy Lumbar Disc Herniation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No