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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04071483
Enrollment
126
Registered
2019-08-28
Start date
2018-10-01
Completion date
2019-09-30
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Epidural

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.

Interventions

PROCEDURECervical transforaminal epidural steroid injection

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

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Pain intensityBefore treatment and at 1 month after treatmentPain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).

Countries

South Korea

Contacts

Primary ContactJimin Heo
knuhmrc@knu.ac.kr+82-53-420-5430
Backup ContactSaeyoung Kim, PhD
saeyoungkim7@gmail.com+82-53-420-5873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026