An observational study in Lumbar Disc Herniation, Lumbar Radiculopathy and Radicular Low Back Pain, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Marmara University · Observational
Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood.
This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.
Transforaminal epidural steroid injection (TFESI) is widely utilized in patients with lumbar disc herniation-related radiculopathy who do not respond adequately to conservative treatment and are not immediate candidates for surgery. While previous studies have demonstrated the overall effectiveness of TFESI, there is limited evidence regarding the temporal characteristics of pain relief following the procedure and how these patterns influence long-term outcomes.
In routine clinical practice, patients may exhibit heterogeneous pain trajectories after TFESI, including early responders, delayed responders, transient responders, or those with minimal or no response. Identifying early pain response patterns that predict treatment success may help clinicians optimize patient counseling, follow-up strategies, and decisions regarding repeat interventions.
In this prospective observational cohort study, adult patients undergoing fluoroscopy-guided TFESI as part of routine clinical care will be followed longitudinally. Pain intensity will be assessed using the Numeric Rating Scale (NRS) before the procedure; at 1 hour post-procedure; every 72 hours during the first 21 days; and at 1, 3, and 6 months. Demographic data, clinical characteristics, and radiological findings from lumbar magnetic resonance imaging will be recorded.
The primary objective is to determine whether early temporal changes in pain intensity following TFESI are associated with treatment success at 3 months. Secondary objectives include evaluating treatment success at 6 months and identifying early pain response thresholds that predict favorable outcomes.
474 studies on the registry are indexed under Intervertebral Disc Displacement; 100 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 117 observational studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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The study population consists of adult patients aged 18 to 65 years with lumbar disc herniation-related radiculopathy who are undergoing fluoroscopy-guided transforaminal epidural steroid injection as part of routine clinical care. All participants have clinically significant radicular pain with a pre-procedural Numeric Rating Scale (NRS) score of 4 or higher and lumbar disc herniation confirmed by magnetic resonance imaging (MRI) at a segmental level consistent with clinical findings.
Patients included in the study are those who have not achieved adequate symptom relief with conservative treatment modalities and are therefore referred for transforaminal epidural steroid injection by the algology clinic. Participants are prospectively followed after the procedure to evaluate temporal changes in pain intensity and their association with clinical treatment success.
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.
Adult patients with lumbar disc herniation-related radiculopathy undergoing routine fluoroscopy-guided transforaminal epidural steroid injection as part of standard clinical care, followed prospectively for pain outcomes.
Procedure: Transforaminal epidural steroid injection
Fluoroscopy-guided transforaminal epidural steroid injection performed as part of routine clinical care. After confirmation of correct needle placement with contrast medium and exclusion of intravascular uptake, a mixture of betamethasone, bupivacaine, and normal saline is injected slowly into the epidural space. This procedure is not assigned by the study and is performed according to standard clinical practice.
Role of Early Temporal Changes in Pain Response on Treatment Success
Association between temporal changes in pain response following transforaminal epidural steroid injection and clinical treatment success. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at baseline (pre-procedure), at 1 hour post-procedure via face-to-face assessment, every 72 hours during the first 21 days, and at 1, 3, and 6 months via telephone follow-up. Temporal patterns of pain response over these time points will be analyzed in relation to clinical treatment success, defined as a ≥50% reduction in NRS score at 3 months compared with baseline.Clinical treatment success is defined as a ≥50% reduction in NRS score at 3 months compared with baseline.
Time frame: Baseline to 6 months after transforaminal epidural steroid injection
Clinical Treatment Success at 3 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 3 months compared with baseline (pre-procedure).
Time frame: 3 months after transforaminal epidural steroid injection
Clinical Treatment Success at 6 Months
Proportion of participants achieving a ≥50% reduction in Numeric Rating Scale (NRS) pain score at 6 months compared with baseline.
Time frame: 6 months after transforaminal epidural steroid injection
Time to Maximum Pain Relief
Time (in days) from transforaminal epidural steroid injection to the lowest recorded Numeric Rating Scale (NRS) pain score during follow-up.
Time frame: Up to 6 months after the procedure
Association Between Radiological Findings and Pain Response
Relationship between lumbar magnetic resonance imaging characteristics (disc herniation level, location, size, and nerve root compression) and temporal pain response patterns following transforaminal epidural steroid injection.
Time frame: Baseline to 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Aug 2026, 6 months later.
Of 45 non-industry observational studies under Intervertebral Disc Displacement, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's planned 6 months is below that.
Counting every sponsor, half of 49 studies reached it within 35 months; a quarter within 13 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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