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

NCT07080307 | Not Yet Recruiting

• 1 other identifier: MAR.FTR.FK.01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sciatica; Low Back Pain; Lumbar Spinal Stenosis; Radiculopathy; Lumbar Disc Herniation

Keywords

sciatica, radiculopathy, lumbar disc herniation, spinal stenosis, low back pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

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

  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

  Baseline, 3 months and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi, İstanbul , Maltepe 34854 Recruiting

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sciatica; Low Back Pain; Spinal Stenosis; Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Faruk Kargıoğlu, Asisstant Doctor

CONTACT

+905304774375; farukkargioglu@outlook.com

Savaş Şencan, Associate Professor

CONTACT

+905370665713; savas-44@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: July 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)