TFESI and Neuropathic Pain in Lumbosacral Radiculopathy

NCT07799155 | Recruiting

• 1 other identifier: 09.2026.778
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbosacral Radiculopathy; Neuropathic Pain From Lumbosacral Radiculopathy; Disc Herniation With Radiculopathy

Keywords

TFESI; Transforaminal Epidural Steroid Injection; Neuropathic Pain Scale; Lumbosacral Radiculopathy; Radicular Pain; Epidural Steroid Injection; Low Back Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 weeks after intervention, and 3 months after intervention

Secondary Outcomes (5)

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

  Baseline, 3 weeks after intervention, and 3 months after intervention

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

  Baseline, 3 weeks after intervention, and 3 months after intervention

• Change in Functional Disability Assessed by Oswestry Disability Index (ODI)

  Baseline, 3 weeks after intervention, and 3 months after intervention

• Association Between Contrast Dispersion Pattern and Clinical Outcomes

  Baseline, 3 weeks after intervention, and 3 months after intervention

• Association Between Pfirrmann Grade and Clinical Outcomes

  Baseline and throughout follow-up assessments up to 3 months

Study Arms (1)

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).

Procedure: Transforaminal Epidural Steroid Injections

Interventions

Transforaminal Epidural Steroid Injections PROCEDURE

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

TFESI Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Neuralgia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Osman Hakan Gündüz, Professor MD

  Marmara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ece Reşit, MD

CONTACT

+90 531 555 49 01; resitece98@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study without masking. All participants will receive the same intervention (TFESI).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants will receive transforaminal epidural steroid injection (TFESI) treatment, and neuropathic pain severity will be evaluated before and after the intervention.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: September 2, 2026
• Study Start: August 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)