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

Lumbosacral Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711121
• Other study ID #: 09.2020.719
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: March 2023

Study information

• Verified date: February 2023
• Source: Istanbul Medeniyet University
• Contact: Ekim Can Ozturk, M.D.
• Phone: +905448294239
• Email: ekimtrilogy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Transforaminal epidural steroid injection
Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.
• Caudal epidural steroid injection
Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Istanbul	Pendik

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Medeniyet University	Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	50 percent pain relief	Number of patients having at least 50 percent pain relief	3 months
Secondary	Oswestry Disability Index	Improvement in disability scores, 0 is the best, 100 is the worst score.	3 months
Secondary	Procedure time	The overall ease of application regarding procedure time.	during procedure
Secondary	Radiation exposure	The exposed radiation dose during the procedures	during procedure