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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05088954
Other study ID # 09.2021.1040
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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...

Study Design


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
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