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

N/ANot Yet RecruitingNCT07080307

Marmara University1,500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Sciatica Low Back Pain Lumbar Spinal Stenosis Radiculopathy Lumbar Disc Herniation

Eligibility

Medical Language ↔ Plain English

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

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.

Time frame: Baseline, 1 hour, 3 months, 6 months after TFESI

Change in functional status measured by Oswestry Disability Index (ODI)

Functional disability will be assessed using the validated ODI questionnaire.

Time frame: Baseline, 3 months, 6 months

Secondary Outcomes

Change in psychological status measured by Beck Depression Inventory (BDI)

Baseline, 3months and 6 months

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

SF-12 will be used to assess the impact of pain and treatment on quality of life.

Time frame: Baseline, 3 months and 6 months

Central Contacts

Faruk Kargıoğlu, Asisstant Doctor

CONTACT

+905304774375 farukkargioglu@outlook.com

Savaş Şencan, Associate Professor