Low Back Pain, Lumbar Disc Herniation, Lumbar Spinal Stenosis, Radiculopathy, Sciatica
Conditions
Keywords
sciatica, radiculopathy, lumbar disc herniation, spinal stenosis, low back pain
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.
Interventions
None listed
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in functional status measured by Oswestry Disability Index (ODI) | Baseline, 3 months, 6 months | Functional disability will be assessed using the validated ODI questionnaire. |
| Change in pain intensity measured by Numeric Rating Scale (NRS) | Baseline, 1 hour, 3 months, 6 months after TFESI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related quality of life measured by SF-12 | Baseline, 3 months and 6 months | SF-12 will be used to assess the impact of pain and treatment on quality of life. |
| Change in psychological status measured by Beck Depression Inventory (BDI) | Depression symptoms will be evaluated using BDI to assess changes related to pain improvement. | Baseline, 3months and 6 months |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFaruk Kargıoğlu, Asisstant Doctor
Backup ContactSavaş Şencan, Associate Professor
Outcome results
None listed