Back to resultsEffect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy
Primary Purpose
Herniated Disk Lumbar, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transforaminal epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Herniated Disk Lumbar
Eligibility Criteria
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...
Sites / Locations
- Marmara UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients diagnosed with metabolic syndrome
Patients without a diagnosis with metabolic syndrome
Arm Description
Outcomes
Primary Outcome Measures
Rate of Successful Response
The primary outcome measure of our study is successful response (>50% reduction in NRS)
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05088954
Brief Title
Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy
Official Title
Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disk Lumbar, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
transforaminal epidural steroid injection
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with metabolic syndrome
Arm Type
Active Comparator
Arm Title
Patients without a diagnosis with metabolic syndrome
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
transforaminal epidural steroid injection
Intervention Description
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 Outcome Measure Information:
Title
Rate of Successful Response
Description
The primary outcome measure of our study is successful response (>50% reduction in NRS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
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.
Time Frame
6 months
Title
Istanbul Low Back Pain Disability Index (ILBPDI)
Description
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.
Time Frame
6 months
Title
Short Form 12 (SF-12)
Description
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.
Time Frame
6 months
Title
Beck Depression Inventory (BPI)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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...
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Savaş şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Buket Süslü
Phone
+905375024088
Email
buket_suslu@hotmail.com
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savaş Şencan
Phone
+905370665713
Email
savasdr44@gmail.com
First Name & Middle Initial & Last Name & Degree
Buket Süslü
Phone
+905375024088
Email
buket_suslu@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy
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