Clinical trial NCT03389620: Transforaminal Versus Lateralized Interlaminar Cervical Epidurals
Official title: Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervicogenic Upper Extremity Radiculopathy
Keywords: CT-fluoroscopy
Corticosteroid injection
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.


Eligibility criteria: Inclusion Criteria:

* Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
* Baseline numerical pain scale (NRS) score \> 4

Exclusion Criteria:

* Recent (i.e., \< 2 months) cervical spine surgery
* Recent (i.e., \< 1 month) cervical epidural or upper extremity corticosteroid injection
* Contraindication or inability to the undergo procedure
* Inability to provide informed consent
* Expected inability to complete follow-up assessment
* Contraindication to receiving contrast material (precluding an epidurogram)

Primary outcomes:
measure: Numerical Rating Scale (averaged over past 24 hours)
timeFrame: 2 months
Secondary outcomes:
measure: NRS (averaged over past 24 hours)
timeFrame: 2 weeks
measure: NRS (averaged over past 24 hours)
timeFrame: 4 months
measure: Change in NRS (averaged over past 24 hours)
timeFrame: Baseline, 2 weeks, 2 months, 4 months
measure: Neck Disability Index (NDI)
timeFrame: 2 weeks
measure: Neck Disability Index (NDI)
timeFrame: 2 months
measure: Neck Disability Index (NDI)
timeFrame: 4 months
measure: Change in Neck Disability Index (NDI)
timeFrame: Baseline, 2 weeks, 2 months, 4 months
measure: EQ-5D at 2 weeks
timeFrame: 2 weeks
measure: EQ-5D at 2 months
timeFrame: 2 months
measure: EQ-5D at 4 months
timeFrame: 4 months
measure: Change in EQ-5D
timeFrame: Baseline, 2 weeks, 2 months, 4 months
measure: Work Ability Index at 2 weeks
timeFrame: 2 weeks
measure: Work Ability Index at 2 months
timeFrame: 2 months
measure: Work Ability Index at 4 months
timeFrame: 4 months
measure: Change in Work Ability Index
timeFrame: 2 week, 3 months, 4 months
measure: Frequency of minor Adverse Events
timeFrame: immediately post-procedure
measure: Frequency of minor Adverse Events
timeFrame: 2 days post procedure
measure: Frequency of major Adverse Events
timeFrame: immediately post-procedure
measure: Frequency of major Adverse Events
timeFrame: 2 days post procedure
measure: Frequency of contrast spread into the neuroforamen for each group
timeFrame: During procedure
measure: Rate of inadvertent intravascular contrast injections
timeFrame: During procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Radiology and Orthopaedic Clinic
state: North Carolina
Study officials:
affiliation: Duke University
name: Timothy Amrhein, MD
role: PRINCIPAL_INVESTIGATOR
References: