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

• Sponsor: Istanbul Medeniyet University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05711121
• Collaborator: Marmara University (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.2
• Patients Per Site Per Month: 11.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbosacral Radiculopathy	Procedure: Transforaminal epidural steroid injection; Procedure: Caudal epidural steroid injection	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients having radicular pain were randomized to either caudal or transforaminal epidural injection groupPatients having radicular pain were randomized to either caudal or transforaminal epidural injection group
• Masking: Double (Participant, Investigator)
• Masking Description: Patients and the investigator assessing the treatment results were blinded to the injection technique.
• Primary Purpose: Treatment
• Official Title: Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
• Actual Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Jun 28, 2023
• Anticipated Study Completion Date: Jul 8, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 50 percent pain relief [3 months]

   Number of patients having at least 50 percent pain relief

Secondary Outcome Measures

1. Oswestry Disability Index [3 months]

   Improvement in disability scores, 0 is the best, 100 is the worst score.

2. Procedure time [during procedure]

   The overall ease of application regarding procedure time.

3. Radiation exposure [during procedure]

   The exposed radiation dose during the procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University School of Medicine	Istanbul	Pendik	Turkey	34899

Sponsors and Collaborators

• Istanbul Medeniyet University
• Marmara University

Investigators

• Study Director: Osman Hakan Gunduz, Prof., Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bilinç Doğruöz Karatekin, Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05711121
• Other Study ID Numbers: 09.2020.719
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bilinç Doğruöz Karatekin, Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation, Istanbul Medeniyet University: epidural injection; radicular pain; disc herniation; lumbosacral radiculopathy; transforaminal injection; caudal injection
• Additional relevant MeSH terms: Radiculopathy

Study Results

No Results Posted as of Feb 2, 2023