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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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

1

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.
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: