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

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: Recruiting
• Conditions: Metabolic Syndrome; Herniated Disk Lumbar
• Intervention / Treatment: Procedure: transforaminal epidural steroid injection

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Savaş Şencan; Phone Number: +905370665713; Email: savasdr44@gmail.com
• Study Contact Backup: Name: Buket Süslü; Phone Number: +905375024088; Email: buket_suslu@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Recruiting
    • Marmara University
    • Contact: Savaş Şencan; Phone Number: +905370665713; Email: savasdr44@gmail.com
    • Contact: Buket Süslü; Phone Number: +905375024088; Email: buket_suslu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is less than 3 months, Patients aged 18 to 65 years

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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	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	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)	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)	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
Beck Depression Inventory (BPI)	Beck Depression Inventory (BPI) measures the physical, emotional and cognitive symptoms seen in depression. It is a self-assessment scale that includes 21 symptom categories. The change in BPI compared to the baseline was measured at the outpatient visit.	6 months

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

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 (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Disease; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Insulin Resistance; Hyperinsulinism; Spinal Diseases; Bone Diseases; Hernia; Syndrome; Metabolic Syndrome; Intervertebral Disc Displacement; Radiculopathy
• 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