Skip to main content
OpenTrials
Completed

NCT Number: NCT05099796

Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy

62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Failed Back Surgery Syndrome Back Pain Epidural Fibrosis Low Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Radiculopathy 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

Istanbul, Turkey (Türkiye)

About this study

Patients with low back and radicular pain related to epidural fibrosis following single-level lumbar discectomy were included. The patients were randomly divided into two groups as the CESI group and TFESI group. Transforaminal epidural steroid injection was applied to the TFESI group (n=31), and caudal epidural steroid injection was applied to the CESI group (n=31). All patients were assessed before the procedure (baseline) and at 1 hour, three weeks, and three months after the procedure using the Numerical Rating Scale (NRS) and at baseline and three weeks and three months using the modified Oswestry Disability Index (mODI). Treatment success was defined as ≥50% decrease in the NRS scores compared to baseline

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 65 years
  • Previous single-level, open, non-fusion discectomy for L4-5 or L5-S1 lumbar disc herniation within the past six months
  • Having epidural fibrosis involving the L4, L5 or S1 nerve root on magnetic resonance imaging
  • Having low back and leg pain for at least six months and unresponsive to conservative therapies
  • A Numerical Rating Scale score of ≥4
  • Having a single-level epidural fibrosis in the operated level and side as assessed by contrast-enhanced spinal magnetic resonance imaging

Exclusion criteria

  • Having a multi-level epidural fibrosis
  • Previous surgery for multi-level disc herniation
  • Previous lumbar fusion surgery
  • Having recurrent disc hernia
  • Having sacroiliac/facet joint pain
  • Having lumbar spinal stenosis, spondylolysis, spondylolisthesis, or scoliosis
  • History of epidural steroid injection within the past six months
  • Having bleeding diathesis
  • Presence of systemic or local infections
  • Pregnancy
  • Known hypersensitivity to the injectates to be applied

Treatment and study plan

Transforaminal Epidural Steroid Injection

Procedure

caudal epidural steroid injection

Procedure

Primary outcomes

  1. Change in pain severity

    Time frame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)

    Numerical Rating Scale (NRS) is a scale for assessing the severity of pain. The numerical rating scale ranges from 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable". The patient chooses the most appropriate number describing the severity of pain (oral version).

  2. Change in disability score

    Time frame: All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)

    Modified Oswestry Disability Index (MODI) is a 10-question questionnaire assessing disability in low back pain. Each question has 6 options. The lowest score for each question is zero and the highest score is 5. High score is associated with increased disability.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Comparison of Caudal Versus Transforaminal Epidural Steroid Injection in Post-lumbar Surgery Syndrome After Single-level Discectomy: A Prospective, Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2021
Registry last updated
Oct 29, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.