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
About this trial
This is an interventional screening trial for Analgesia, Epidural
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.
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
NCT ID
NCT04071483
First Posted
August 26, 2019
Last Updated
September 5, 2019
Sponsor
Kyungpook National University Hospital
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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