An observational study in Sciatica, Low Back Pain and Lumbar Spinal Stenosis, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Marmara University · Observational
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 88 across 24 observational studies indexed under Sciatica.
Browse Sciatica studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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