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

NCT ID: NCT05711121

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Lumbosacral Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients having radicular pain were randomized to either caudal or transforaminal epidural injection group
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Patients and the investigator assessing the treatment results were blinded to the injection technique.

Study Groups

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S1 transforaminal

The group receiving S1 transforaminal epidural steroid injection

Group Type ACTIVE_COMPARATOR

Transforaminal epidural steroid injection

Intervention Type PROCEDURE

Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.

Caudal

The group receiving caudal epidural steroid injection

Group Type ACTIVE_COMPARATOR

Caudal epidural steroid injection

Intervention Type PROCEDURE

Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.

Interventions

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Transforaminal epidural steroid injection

Fluoroscopy-guided transforaminal epidural injection for radicular pain resulting from a disc herniation.

Intervention Type PROCEDURE

Caudal epidural steroid injection

Fluoroscopy-guided caudal epidural injection for radicular pain resulting from a disc herniation.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role collaborator

Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Bilinç Doğruöz Karatekin

Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osman Hakan Gunduz, Prof.

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University School of Medicine

Istanbul, Pendik, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ekim Can Ozturk, M.D.

Role: CONTACT

+905448294239

Savas Sencan, Assoc. Prof.

Role: CONTACT

+905370665713

Facility Contacts

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Savas Sencan, Assoc. Prof.

Role: primary

+905370665713

Rekib Sacaklidir, M.D.

Role: backup

+905538044082

Other Identifiers

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09.2020.719

Identifier Type: -

Identifier Source: org_study_id

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