SciaticaNCT07080307
Artificial Intelligence (AI)-Based Prediction of Treatment Response in Sciatica Patients Receiving Transforaminal Epidural Steroid Injection
An observational study of Sciatica and Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica, Low Back Pain, Lumbar Spinal Stenosis
- How many people
- 1,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara Üniversitesi Tıp Fakültesi, İstanbul , Maltepe 34854 Recruiting
Istanbul, Maltepe, 34854
About this study
Official title: Artificial Intelligence-Based Predictive Models for Estimating Treatment Response in Sciatica Patients Treated With Transforaminal Epidural Steroid Injection (TFESI)
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.
- Keywords
- sciatica, radiculopathy, lumbar disc herniation, spinal stenosis, low back pain
- Medical subject headings
- Sciatica, Low Back Pain, Spinal Stenosis, Radiculopathy, Intervertebral Disc Displacement
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
Change in psychological status measured by Beck Depression Inventory (BDI)
Baseline, 3months and 6 months
Measured: 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.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080307
- Sponsor's protocol ID
- MAR.FTR.FK.01
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Based Predictive Models for Estimating Treatment Response in Sciatica Patients Treated With Transforaminal Epidural Steroid Injection (TFESI)
- ClinicalTrials.gov ID
- NCT07080307
- Acronym / sponsor ID
- MAR.FTR.FK.01
- Keywords
- sciatica, radiculopathy, lumbar disc herniation, spinal stenosis, low back pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Malignancy
- Coagulation disorders
- Pregnancy
- History of allergic reaction to the injected substances
- History of major psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pain intensity measured by Numeric Rating Scale (NRS)
Time frame: 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.
Change in functional status measured by Oswestry Disability Index (ODI)
Time frame: Baseline, 3 months, 6 months
Functional disability will be assessed using the validated ODI questionnaire.
2 secondary outcomes
Change in psychological status measured by Beck Depression Inventory (BDI)
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
Time frame: Baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica and Low Back Pain, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faruk Kargıoğlu, Asisstant Doctor (+905304774375, farukkargioglu@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Numeric Rating Scale (NRS) (time frame: Baseline, 1 hour, 3 months, 6 months after TFESI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.