Efficacy of TFESI in Lumbar Radicular Pain

April 13, 2026 updated by: Emine Esra Bilir, Ankara City Hospital Bilkent

Efficacy of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain

The goal of this retrospective study is to evaluate the effectiveness of transforaminal epidural steroid injections (TFESI) in patients with radicular low back pain caused by lumbar disc herniation who did not improve with conservative treatment.

The main questions it aims to answer are:

How effective is TFESI in reducing pain and improving physical function over a three-month period?

Can this procedure serve as a viable alternative to surgery for patients with persistent radiculopathy?

Participants aged 18 to 90 underwent image-guided injections and were monitored for three months. Researchers tracked changes in their pain levels (using the Visual Analog Scale) and their ability to perform daily activities (using the Oswestry Disability Index) to determine the treatment's success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye), 06800
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We included 252 patients admitted to unilateral or bilateral radiating pain in the lower extremity associated with Low Back Pain.

Description

Inclusion Criteria:

  • Between 18 and 90 years,
  • Presence of Low Back Pain with unilateral or bilateral pain radiating to the lower extremity,
  • Duration of symptoms for at least three months and unresponsive to conservative management,
  • Evidence of lumbar intervertebral disc herniation confirmed by MRI within the last six months

Exclusion Criteria:

  • Prior lumbar ESI within 3 months,
  • History of polyneuropathy or entrapment neuropathy,
  • Presence of bleeding diathesis,
  • Systemic or local infections,
  • Having systemic and rheumatic diseases associated with peripheral nerve involvement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with radicular low back pain caused by lumbar disc herniation
Procedure: transforaminal epidural steroid injections (TFESI)
TFESI procedure was performed under sterile conditions, and the injection area was sterilized with povidone-iodine and a sterile drape was laid. To visualize the foramen, the fluoroscopy unit was rotated cranially and obliquely at an angle between 5 and 20 degrees, and 1% lidocaine was injected subcutaneously as a local anesthetic. A Quincke 90mm 22 gauge spinal needle was inserted under the intermittent guidance of fluoroscopy. The needle was advanced into the subpedicular space, proceeding along the path corresponding to the 6 o'clock position. Needle placement was confirmed with a lateral fluoroscopic image.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: baseline, the 2nd weeks, and the 3rd months
(VAS: 0-10)
baseline, the 2nd weeks, and the 3rd months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional status,
Time Frame: baseline, the 2nd weeks, and the 3rd months
Oswestry Disability Index (ODI)
baseline, the 2nd weeks, and the 3rd months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Bilir, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

August 15, 2025

Study Completion (Actual)

December 20, 2025

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TABED 1-25-1862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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