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

Not Applicable

Recruiting

• Conditions: Lumbosacral Radiculopathy

• Registration Number: NCT05711121
• Lead Sponsor: Istanbul Medeniyet University

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-01-09
• Status Verified: 2023-02
• Primary Completion: 2023-02
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
50 percent pain relief	3 months	Number of patients having at least 50 percent pain relief

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Istanbul, Pendik, Turkey