Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy

November 26, 2025 updated by: Marmara University

Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy

Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

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

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is at least 3 months, Patients aged 18 and above

Exclusion Criteria:

  • the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients diagnosed with metabolic syndrome
Procedure: transforaminal epidural steroid injection
In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.
Active Comparator: Patients without a diagnosis with metabolic syndrome
Procedure: transforaminal epidural steroid injection
In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Successful Response
Time Frame: 6 months
The primary outcome measure of our study is successful response (>50% reduction in NRS)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: 6 months
The patient is asked to give a score between 1 and 10 to explain the pain level. The change in NRS compared to the baseline was measured at the outpatient visit.
6 months
Istanbul Low Back Pain Disability Index (ILBPDI)
Time Frame: 6 months
Istanbul Low Back Pain Disability Index (ILBPDI) is a scale developed to evaluate functional disability in patients with chronic low back pain, scoring 18 subjects. The change in ILBPDI compared to the baseline was measured at the outpatient visit.
6 months
Short Form 12 (SF-12)
Time Frame: 6 months
Short Form 12 (SF-12) is a quality of life assessment scale consisting of 8 sub-dimensions and 12 items. The change in SF-12 compared to baseline is measured at the outpatient visit.
6 months

Collaborators and Investigators

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

Sponsor

Marmara University

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)

May 1, 2024

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2021.1040

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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