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NCT Number: NCT05088954

Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in 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.

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Key information

Conditions

Herniated Disk Lumbar Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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...

Treatment and study plan

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.

Primary outcomes

  1. Rate of Successful Response

    Time frame: 6 months

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2021
Registry last updated
Dec 4, 2025

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.

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