Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis
1 other identifier
interventional
126
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedSeptember 9, 2019
September 1, 2019
11 months
August 26, 2019
September 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Intravascular injection
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
During procedure
Secondary Outcomes (1)
Pain intensity
Before treatment and at 1 month after treatment
Study Arms (2)
Moderate stenosis
EXPERIMENTALModerate 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 stenosis
ACTIVE COMPARATORSevere cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width
Interventions
Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
Eligibility Criteria
You may qualify if:
- Patients with radiating pain from cervical spinal stenosis and herniated nucleus pulposus.
You may not qualify if:
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook national university hospital
Daegu, 700-412, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
October 1, 2018
Primary Completion
August 31, 2019
Study Completion
September 30, 2019
Last Updated
September 9, 2019
Record last verified: 2019-09