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

Study Overview
=================
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.

Official Title
-----------------
Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study

Conditions
-----------------
Analgesia, Epidural

Intervention / Treatment
-----------------
* Procedure: Cervical transforaminal epidural steroid injection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate stenosis<br>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. | Procedure: Cervical transforaminal epidural steroid injection<br>* Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.<br>|
| Active Comparator: Severe stenosis<br>Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width | Procedure: Cervical transforaminal epidural steroid injection<br>* Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). | Before treatment and at 1 month after treatment |