Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

NCT ID: NCT05551676

Last Updated: 2022-09-23

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

2022-06-22

Study Completion Date

2023-12-22

Brief Summary

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Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.

Detailed Description

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It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.

Conditions

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Lumbar Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transforaminal group

Transforaminal steroid injection will be applied, 30 patients

Group Type ACTIVE_COMPARATOR

transforaminal group

Intervention Type PROCEDURE

Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.

Lateral parasagittal group

Lateral parasagittal steroid injection will be applied, 30 patients

Group Type ACTIVE_COMPARATOR

Lateral parasagittal group

Intervention Type PROCEDURE

Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.

Interventions

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transforaminal group

Epidural steroid injection will be applied with transforaminal approach accompanied by fluoroscopy.

Intervention Type PROCEDURE

Lateral parasagittal group

Epidural steroid injection will be applied with lateral parasagittal approach accompanied by scopy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Unilateral low back pain, radiculopathy

Exclusion Criteria

* malignancy
* past back surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ömer Taylan AKKAYA

Role: STUDY_DIRECTOR

Diskapi TRH

Hüseyin Alp Alptekin

Role: STUDY_CHAIR

Diskapi TRH

Ezgi Can

Role: PRINCIPAL_INVESTIGATOR

Diskapi TRH

Locations

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Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Lomber Epidural

Identifier Type: -

Identifier Source: org_study_id

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