Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbosacral Radiculopathy
• Intervention / Treatment: Procedure: Transforaminal epidural steroid injection; Procedure: Caudal epidural steroid injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Pendik
    • Istanbul, Pendik, Turkey, 34899
      • Recruiting
      • Marmara University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: S1 transforaminal; The group receiving S1 transforaminal epidural steroid injection	Procedure: Transforaminal epidural steroid injection; Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.
Active Comparator: Caudal; The group receiving caudal epidural steroid injection	Procedure: Caudal epidural steroid injection; Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50 percent pain relief	Number of patients having at least 50 percent pain relief	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Improvement in disability scores, 0 is the best, 100 is the worst score.	3 months
Procedure time	The overall ease of application regarding procedure time.	during procedure
Radiation exposure	The exposed radiation dose during the procedures	during procedure

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Collaborators: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: epidural injection; disc herniation; radicular pain; lumbosacral radiculopathy; transforaminal injection; caudal injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 09.2020.719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient data, statistics and study protocol can be shared.
• IPD Sharing Time Frame: 1 week
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No