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

NCT ID: NCT05088954

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Herniated Disk Lumbar Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

transforaminal epidural steroid injection
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patients diagnosed with metabolic syndrome

Group Type ACTIVE_COMPARATOR

transforaminal epidural steroid injection

Intervention Type 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 without a diagnosis with metabolic syndrome

Group Type ACTIVE_COMPARATOR

transforaminal epidural steroid injection

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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...
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2021.1040

Identifier Type: -

Identifier Source: org_study_id

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