NCT07538765

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Transforaminal Epidural Steroid InjectionRadicular Low Back Pain

Keywords

Lumbar radicular pain, transforaminal epidural steroid injection, interventional pain management.

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    (VAS: 0-10)

    baseline, the 2nd weeks, and the 3rd months

Secondary Outcomes (1)

  • functional status,

    baseline, the 2nd weeks, and the 3rd months

Study Arms (1)

patients with radicular low back pain caused by lumbar disc herniation

Procedure: transforaminal epidural steroid injections (TFESI)

Interventions

transforaminal epidural steroid injections (TFESI)PROCEDURE

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.

patients with radicular low back pain caused by lumbar disc herniation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • Roy C, Chatterjee N, Patro SN, Chakraborty A, Vijay Kumar GR, Sengupta R. The efficacy of transforaminal epidural steroid injections in lumbosacral radiculopathy. Neurol India. 2011 Sep-Oct;59(5):685-9. doi: 10.4103/0028-3886.86541.

    PMID: 22019651RESULT

  • Koc Z, Ozcakir S, Sivrioglu K, Gurbet A, Kucukoglu S. Effectiveness of physical therapy and epidural steroid injections in lumbar spinal stenosis. Spine (Phila Pa 1976). 2009 May 1;34(10):985-9. doi: 10.1097/BRS.0b013e31819c0a6b.

    PMID: 19404172RESULT

Study Officials

  • Bilir

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

September 1, 2024

Primary Completion

August 15, 2025

Study Completion

December 20, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)