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

Not Applicable

• Conditions: Metabolic Syndrome; Herniated Disk Lumbar
• Interventions: Procedure: transforaminal epidural steroid injection

• Registration Number: NCT05088954
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with metabolic syndrome	transforaminal epidural steroid injection	-
Patients without a diagnosis with metabolic syndrome	transforaminal epidural steroid injection	-

Primary Outcome Measures

Name	Time	Method
Rate of Successful Response	6 months	The primary outcome measure of our study is successful response (\>50% reduction in NRS)

Secondary Outcome Measures

Name	Time	Method
Short Form 12 (SF-12)	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.
Numerical Rating Scale	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.
Istanbul Low Back Pain Disability Index (ILBPDI)	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.
Beck Depression Inventory (BPI)	6 months	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.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey