Back to resultsCaudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
Primary Purpose
Lumbosacral Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transforaminal epidural steroid injection
Caudal epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Lumbosacral Radiculopathy focused on measuring epidural injection, radicular pain, disc herniation, lumbosacral radiculopathy, transforaminal injection, caudal injection
Eligibility Criteria
Inclusion Criteria: Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression. Exclusion Criteria: History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases
Sites / Locations
- Marmara University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
S1 transforaminal
Caudal
Arm Description
The group receiving S1 transforaminal epidural steroid injection
The group receiving caudal epidural steroid injection
Outcomes
Primary Outcome Measures
50 percent pain relief
Number of patients having at least 50 percent pain relief
Secondary Outcome Measures
Oswestry Disability Index
Improvement in disability scores, 0 is the best, 100 is the worst score.
Procedure time
The overall ease of application regarding procedure time.
Radiation exposure
The exposed radiation dose during the procedures
Full Information
NCT ID
NCT05711121
First Posted
January 9, 2023
Last Updated
February 13, 2023
Sponsor
Istanbul Medeniyet University
Collaborators
Marmara University
1. Study Identification
Unique Protocol Identification Number
NCT05711121
Brief Title
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
Official Title
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
Collaborators
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacies of two different interventional techniques (Caudal epidural steroid injection and S1 transforaminal epidural steroid injection) for the treatment of unilateral S1 radiculopathy.
Detailed Description
Epidural steroid injections are commonly performed for the treatment of radicular pain resulting from a disc herniation. There are 3 different methods to deliver steroids to epidural area which are caudal, interlaminar and transforaminal routes. Lower lumbar and sacral radiculopathies can be managed with caudal epidural steroid injection which is generally quite easier to perform in comparison to transforaminal injection. Transforaminal epidural injection provides injectate to reach anterior epidural area and is the most target specific technique among others. In the present study investigators aim is to compare the success rates of these two different procedures regarding unilateral S1 radiculopathy. The patients referring to the pain medicine outpatient clinic of a university hospital for unilateral radicular pain and diagnosed S1 radiculopathy were planned to be randomized into these two different intervention groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy
Keywords
epidural injection, radicular pain, disc herniation, lumbosacral radiculopathy, transforaminal injection, caudal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
Masking
ParticipantInvestigator
Masking Description
Patients and the investigator assessing the treatment results were blinded to the injection technique.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S1 transforaminal
Arm Type
Active Comparator
Arm Description
The group receiving S1 transforaminal epidural steroid injection
Arm Title
Caudal
Arm Type
Active Comparator
Arm Description
The group receiving caudal epidural steroid injection
Intervention Type
Procedure
Intervention Name(s)
Transforaminal epidural steroid injection
Intervention Description
Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.
Intervention Type
Procedure
Intervention Name(s)
Caudal epidural steroid injection
Intervention Description
Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.
Primary Outcome Measure Information:
Title
50 percent pain relief
Description
Number of patients having at least 50 percent pain relief
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Improvement in disability scores, 0 is the best, 100 is the worst score.
Time Frame
3 months
Title
Procedure time
Description
The overall ease of application regarding procedure time.
Time Frame
during procedure
Title
Radiation exposure
Description
The exposed radiation dose during the procedures
Time Frame
during procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral radicular pain resulting from a paracentral L5-S1 disc herniation causing S1 nerve root compression.
Exclusion Criteria:
History of previous surgery, pregnancy, neurological disorders, bleeding diathesis, contrast medium allergy, spinal disorders, rheumatologic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekim Can Ozturk, M.D.
Phone
+905448294239
Email
ekimtrilogy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Savas Sencan, Assoc. Prof.
Phone
+905370665713
Email
savas-44@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osman Hakan Gunduz, Prof.
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Marmara University School of Medicine
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Savas Sencan, Assoc. Prof.
Phone
+905370665713
Email
savas-44@gmail.com
First Name & Middle Initial & Last Name & Degree
Rekib Sacaklidir, M.D.
Phone
+905538044082
Email
rekibsacakli@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient data, statistics and study protocol can be shared.
IPD Sharing Time Frame
1 week
Learn more about this trial
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
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