Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis

NCT ID: NCT04071483

Last Updated: 2019-09-09

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-09-30

Brief Summary

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This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection

Detailed Description

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Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.

The incidence of intravascular injection during CTFESI was known as 20.6% \~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.

To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.

Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.

Conditions

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Analgesia, Epidural

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

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Moderate stenosis

Moderate cervical neural foraminal stenosis is narrowest width of the neural foramen was \>50% of the width of the width of the extraforaminal nerve root at the level of the anterior margin of the superior articular process.

Group Type EXPERIMENTAL

Cervical transforaminal epidural steroid injection

Intervention Type PROCEDURE

Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.

Severe stenosis

Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width

Group Type ACTIVE_COMPARATOR

Cervical transforaminal epidural steroid injection

Intervention Type PROCEDURE

Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.

Interventions

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Cervical transforaminal epidural steroid injection

Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saeyoung Kim, MD, PhD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyungpook national university hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jimin Heo

Role: CONTACT

+82-53-420-5430

Saeyoung Kim, PhD

Role: CONTACT

+82-53-420-5873

Facility Contacts

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Jimin Heo

Role: primary

82-53-420-5430

Other Identifiers

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2018-06-009-001

Identifier Type: -

Identifier Source: org_study_id

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