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Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

NCT ID: NCT03389620

Last Updated: 2025-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-05

Study Completion Date

2023-09-16

Brief Summary

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The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.

Detailed Description

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Conditions

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Cervicogenic Upper Extremity Radiculopathy

Keywords

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CT-fluoroscopy Corticosteroid injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transforaminal Cervical Epidural Corticosteroid Injections

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

Lateralized Interlaminar Epidural Corticosteroid Injections

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

Interventions

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dexamethasone

0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
* Baseline numerical pain scale (NRS) score \> 4

Exclusion Criteria

* Recent (i.e., \< 2 months) cervical spine surgery
* Recent (i.e., \< 1 month) cervical epidural or upper extremity corticosteroid injection
* Contraindication or inability to the undergo procedure
* Inability to provide informed consent
* Expected inability to complete follow-up assessment
* Contraindication to receiving contrast material (precluding an epidurogram)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Amrhein, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Radiology and Orthopaedic Clinic

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00083262

Identifier Type: -

Identifier Source: org_study_id