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Completed

NCT Number: NCT07538765

Efficacy of TFESI 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.

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Key information

Conditions

Transforaminal Epidural Steroid Injection Radicular Low Back Pain

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Visual analog scale

    Time frame: baseline, the 2nd weeks, and the 3rd months

    (VAS: 0-10)

Secondary outcomes

  1. functional status,

    Time frame: baseline, the 2nd weeks, and the 3rd months

    Oswestry Disability Index (ODI)

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Efficacy of Transforaminal Epidural Steroid Injections in Lumbar Radicular Pain

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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