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NCT Number: NCT07799155

TFESI and Neuropathic Pain in 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.

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Key information

Conditions

Lumbosacral Radiculopathy Back Pain Disc Herniation With Radiculopathy Low Back Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain From Lumbosacral Radiculopathy Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation"

Istanbul, 34854, Turkey (Türkiye)

Location status: Recruiting

Location contact

Osman Hakan Gündüz, Prof. MD

CONTACT

[email protected]

+90 532 483 06 86

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Severe uncontrolled systemic disease
  • Cognitive impairment preventing completion of assessment scales
  • Patients unwilling to participate or unable to attend follow-up visits

Treatment and study plan

Transforaminal Epidural Steroid Injections

Procedure

Transforaminal epidural steroid injection will be performed under fluoroscopic guidance for the treatment of lumbosacral radiculopathy.

Primary outcomes

  1. Change in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS)

    Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention

    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.

Secondary outcomes

  1. Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)

    Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention

    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.

  2. Change in Neuropathic Pain Symptoms Assessed by Douleur Neuropathique 4 (DN4)

    Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention

    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.

  3. Change in Functional Disability Assessed by Oswestry Disability Index (ODI)

    Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention

    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.

  4. Association Between Contrast Dispersion Pattern and Clinical Outcomes

    Time frame: Baseline, 3 weeks after intervention, and 3 months after intervention

    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.

  5. Association Between Pfirrmann Grade and Clinical Outcomes

    Time frame: Baseline and throughout follow-up assessments up to 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ece Reşit, MD

CONTACT

[email protected]

+90 531 555 49 01

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of the Effect of Transforaminal Epidural Steroid Injection on Neuropathic Pain Using the Neuropathic Pain Scale in Patients With Lumbosacral Radiculopathy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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