An interventional study of Transforaminal Epidural Steroid Injections in Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy and Disc Herniation With Radiculopathy, sponsored by Marmara University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
Patients with lumbosacral radiculopathy frequently experience neuropathic pain due to nerve root compression. Transforaminal epidural steroid injection (TFESI) is commonly used for pain relief in these patients. This study aims to evaluate the effect of TFESI on neuropathic pain severity using the Neuropathic Pain Scale (NPS) in patients with lumbosacral radiculopathy. Clinical outcomes before and after the procedure will be compared.
Lumbosacral radiculopathy is a common cause of chronic low back and leg pain and is frequently associated with neuropathic pain symptoms resulting from nerve root compression. Neuropathic pain may significantly impair quality of life and functional capacity. Transforaminal epidural steroid injection (TFESI) is a minimally invasive interventional procedure widely used in the management of radicular pain.
The aim of this prospective interventional study is to evaluate the effectiveness of TFESI on neuropathic pain severity in patients with lumbosacral radiculopathy. Neuropathic pain severity will be assessed using the Neuropathic Pain Scale (NPS). Secondary clinical evaluations may include pain intensity and functional status assessments.
Eligible patients diagnosed with lumbosacral radiculopathy and scheduled for TFESI treatment will be enrolled in the study. Clinical assessments will be performed before the procedure and during follow-up visits after the intervention. The study findings are expected to contribute to the understanding of the effects of TFESI on neuropathic pain components in patients with lumbosacral radiculopathy.
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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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Participants with lumbosacral radiculopathy will receive transforaminal epidural steroid injection (TFESI) treatment. Neuropathic pain severity will be evaluated before and after the intervention using the Neuropathic Pain Scale (NPS).
Procedure: Transforaminal Epidural Steroid Injections
Transforaminal epidural steroid injection will be performed under fluoroscopic guidance for the treatment of lumbosacral radiculopathy.
Change in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS)
hange in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS) The primary outcome measure is the change in neuropathic pain severity assessed using the Neuropathic Pain Scale (NPS) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The NPS ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). Changes in NPS scores will be assessed from baseline to 3 weeks and 3 months after the intervention.
Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention
Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)
hange in Pain Intensity Assessed by the Numeric Rating Scale (NRS) Pain intensity will be evaluated using the Numeric Rating Scale (NRS) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The NRS ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcomes). Changes in NRS scores will be assessed from baseline to 3 weeks and 3 months after the intervention.
Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention
Change in Neuropathic Pain Symptoms Assessed by Douleur Neuropathique 4 (DN4)
Change in Neuropathic Pain Symptoms Assessed by the Douleur Neuropathique 4 (DN4) Questionnaire Neuropathic pain symptoms will be evaluated using the Douleur Neuropathique 4 (DN4) questionnaire before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The DN4 score ranges from 0 to 10, with higher scores indicating more severe neuropathic pain symptoms (worse outcomes). Changes in DN4 scores will be assessed from baseline to 3 weeks and 3 months after the intervention.
Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention
Change in Functional Disability Assessed by Oswestry Disability Index (ODI)
Change in Functional Disability Assessed by the Oswestry Disability Index (ODI) Functional disability and limitations in daily living activities will be evaluated using the Oswestry Disability Index (ODI) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The ODI score ranges from 0 to 100, with higher scores indicating greater functional disability (worse outcomes). Changes in ODI scores will be assessed from baseline to 3 weeks and 3 months after the intervention.
Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention
Association Between Contrast Dispersion Pattern and Clinical Outcomes
The change in neuropathic pain severity according to the epidural contrast dispersion pattern observed during transforaminal epidural steroid injection (TFESI) will be evaluated. The epidural contrast dispersion pattern will be classified as intraneural, extraneural, or paraneural based on fluoroscopic imaging of contrast distribution around the nerve root. Neuropathic pain severity will be assessed using the Neuropathic Pain Scale (NPS), which ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). The change in NPS score from baseline will be compared among the three contrast dispersion pattern categories.
Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention
Association Between Pfirrmann Grade and Clinical Outcomes
The change in neuropathic pain severity according to the severity of lumbar nerve root compression will be evaluated. Lumbar nerve root compression will be assessed using the modified Pfirrmann grading system based on lumbar magnetic resonance imaging findings. The modified Pfirrmann grading system ranges from Grade I to Grade IV, with higher grades indicating more severe nerve root compression (worse radiological findings). Neuropathic pain severity will be assessed using the Neuropathic Pain Scale (NPS), which ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). Changes in NPS scores from baseline to follow-up assessments will be compared according to the modified Pfirrmann grade.
Time frame: Baseline and throughout follow-up assessments up to 3 months
Plan to share: No — ndividual participant data (IPD) will not be publicly shared in order to protect participant confidentiality and privacy. Aggregate study findings may be published in scientific presentations or peer-reviewed journals.
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