Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02095197
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2014-03-20
Brief Title:
C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of Standardized C7-T1 Epidural Steroid Injections Versus Targeted Injection Via Cervical Epidural Catheter for the Treatment of Cervical Radicular Pain
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cervical radicular pain is a common disabling problem occurs in 83100000 individuals per year Symptoms are most often caused by intervertebral disc herniation 219 or central or foraminal stenosis from spondylosis 684 Patients complain of pain in the head neck scapula or arm The diagnosis of radicular pain is made clinically by history and physical examination supported by imaging studies and electrodiagnostic tests No study has compared the differences in pain medication utilization functional outcomes or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine In theory the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique The investigators hypothesize that this technique results in superior pain control decreased medication use improved function and fewer repeat injections This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections
Detailed Description:
Cervical radicular pain is a common painful disabling problem often treated by epidural steroid injection ESI Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control function decreased analgesic use and lower surgical incidence as compared to standard CIESI at C7-T1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STU00089080 | OTHER | Northwestern University IRB | None |