Trials / Completed
CompletedNCT02095197
C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Northwestern University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Triamcinolone 80mg | C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-03-24
- Last updated
- 2017-03-28
- Results posted
- 2017-03-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02095197. Inclusion in this directory is not an endorsement.