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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05088954
• Other study ID #: 09.2021.1040
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2022

Study information

• Verified date: October 2021
• Source: Marmara University
• Contact: Savas sencan
• Phone: +905370665713
• Email: savasdr44[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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...

Related Conditions & MeSH terms

• Herniated Disk Lumbar
• Intervertebral Disc Displacement
• Metabolic Syndrome
• Radiculopathy
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Successful Response	The primary outcome measure of our study is successful response (>50% reduction in NRS)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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