Lumbosacral RadiculopathyNCT07799155
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
A study testing Transforaminal Epidural Steroid Injections in people with Lumbosacral Radiculopathy and Neuropathic Pain From Lumbosacral Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy, Disc Herniation With Radiculopathy
- What is being tested?
- Transforaminal Epidural Steroid Injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2026to 20 Feb 2027
- Phase
- Interventional
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Patients diagnosed with lumbosacral radiculopathy based on clinical evaluation and lumbar MRI findings
- Presence of neuropathic pain symptoms associated with lumbosacral radiculopathy
- Patients scheduled to undergo transforaminal epidural steroid injection (TFESI)
- Patients able to understand and complete the study questionnaires and scales
- Voluntary written informed consent provided
Who cannot join
- Previous lumbar spinal surgery
- Cauda equina syndrome or progressive neurological deficit
- Spinal malignancy, infection, or acute vertebral fracture
- Pregnancy or breastfeeding
- Coagulation disorders or current anticoagulant therapy contraindicating injection procedures
- Known allergy to contrast agents, local anesthetics, or corticosteroids
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- Severe uncontrolled systemic disease
- Cognitive impairment preventing completion of assessment scales
- Patients unwilling to participate or unable to attend follow-up visits
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, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation"
Istanbul, Istanbul, 34854
Osman Hakan Gündüz, Prof. MD, +90 532 483 06 86, drhakang@gmail.com
About this study
Official title: Evaluation of the Effect of Transforaminal Epidural Steroid Injection on Neuropathic Pain Using the Neuropathic Pain Scale in Patients With Lumbosacral Radiculopathy
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.
Read the detailed description
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.
- Conditions
- Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy, Disc Herniation With Radiculopathy
- Being tested
- Transforaminal Epidural Steroid Injections
- Keywords
- TFESI, Transforaminal Epidural Steroid Injection, Neuropathic Pain Scale, Lumbosacral Radiculopathy, Radicular Pain, Epidural Steroid Injection, Low Back Pain, Neuropathic Pain
- Medical subject headings
- Low Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural Steroid InjectionsProcedure or surgery
Transforaminal epidural steroid injection will be performed under fluoroscopic guidance for the treatment of lumbosacral radiculopathy.
| Study group | Role | What they receive |
|---|---|---|
| TFESI Group | Experimental | 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). Receives: Procedure: Transforaminal Epidural Steroid Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 weeks after intervention, and 3 months after intervention
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and throughout follow-up assessments up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start11 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive transforaminal epidural steroid injection (TFESI) treatment, and neuropathic pain severity will be evaluated before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osman Hakan Gündüz, Professor MD, Principal investigator, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799155
- Sponsor's protocol ID
- 09.2026.778
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.