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

NCT05088954 | Completed

• 1 other identifier: 09.2021.1040
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herniated Disk Lumbar; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Response

  The primary outcome measure of our study is successful response (\>50% reduction in NRS)

  6 months

Secondary Outcomes (3)

• Numerical Rating Scale

  6 months

• Istanbul Low Back Pain Disability Index (ILBPDI)

  6 months

• Short Form 12 (SF-12)

  6 months

Study Arms (2)

Patients diagnosed with metabolic syndrome

ACTIVE COMPARATOR

Procedure: transforaminal epidural steroid injection

Patients without a diagnosis with metabolic syndrome

ACTIVE COMPARATOR

Procedure: transforaminal epidural steroid injection

Interventions

transforaminal epidural steroid injection PROCEDURE

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.

Patients diagnosed with metabolic syndrome; Patients without a diagnosis with metabolic syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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...

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: transforaminal epidural steroid injection

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 22, 2021
• Study Start: May 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

TU (1)