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

Primary Purpose

Analgesia, Epidural

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cervical transforaminal epidural steroid injection
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Analgesia, Epidural

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kyungpook national university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moderate stenosis

Severe stenosis

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Intravascular injection
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy

Secondary Outcome Measures

Pain intensity
Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).

Full Information

First Posted
August 26, 2019
Last Updated
September 5, 2019
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04071483
Brief Title
Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis
Official Title
Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Epidural

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moderate stenosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Severe stenosis
Arm Type
Active Comparator
Arm Description
Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width
Intervention Type
Procedure
Intervention Name(s)
Cervical transforaminal epidural steroid injection
Intervention Description
Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
Primary Outcome Measure Information:
Title
Intravascular injection
Description
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Before treatment and at 1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jimin Heo
Phone
+82-53-420-5430
Email
knuhmrc@knu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Saeyoung Kim, PhD
Phone
+82-53-420-5873
Email
saeyoungkim7@gmail.com
Facility Information:
Facility Name
Kyungpook national university hospital
City
Daegu
ZIP/Postal Code
700-412
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimin Heo
Phone
82-53-420-5430
Email
knuhmrc@knu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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