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

October 21, 2021 updated by: Marmara University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

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
      • Istanbul, Turkey
        • Marmara University Pendik Training and Research 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transforaminal epidural steroid injection (TESI) group

This procedure was applied only once.

1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 40 mg (1mL) of triamcinolone acetonide, 2 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected.
Procedure: Transforaminal epidural steroid injection
Active Comparator: Caudal epidural steroid injection (CESI) group

This procedure was applied only once

1 to 2 cc of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized which showed bilateral L5-S3 distribution without vascular flow. A mixture of 40 mg (1mL) of triamcinolone acetonide, 7 cc of physiological saline, and 2 cc (0.5%) of bupivacaine was injected. A total of 10 cc mixture was used for CESI.
Procedure: Caudal epidural steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)
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.
All patients were assessed from baseline to each checkpoint (at 1 hour, three weeks, and three months after the procedure)

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Study Director: Savas Sencan, Assoc. Prof., Marmara University Pendik Training and Research Hospital

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)

January 5, 2016

Primary Completion (Actual)

May 11, 2021

Study Completion (Actual)

May 11, 2021

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2014.0085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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