Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Transforaminal Cervical Epidural Corticosteroid Injections
Intervention: dexamethasone (Drug)
Lateralized Interlaminar Epidural Corticosteroid Injections
Intervention: dexamethasone (Drug)
Outcomes
Primary Outcomes
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)
Time Frame: Baseline to 2 months
The pain numerical rating scale (NRS) is a well-validated tool for quantitatively assessing patients' pain. The NRS asks patients to rate their current pain intensity on an 11-point scale ranging from 0 ("no pain") to 10 ("worst possible pain")
Secondary Outcomes
- Change in Work Ability Index (WAI) Absenteeism(Baseline, 2 weeks, 2 months, 4 months)
- Change in Work Ability Index (WAI) Presenteeism(Baseline, 2 weeks, 2 months, 4 months)
- Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)(Baseline, 2 weeks, 4 months)
- Change in Neck Disability Index (NDI)(Baseline, 2 weeks, 2 months, 4 months)
- Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)(Baseline, 2 weeks, 2 months, 4 months)
- Change in EuroQol-5 Dimension (EQ-5D) Index Score(Baseline, 2 weeks, 2 months, 4 months)
- Number of Participants With Minor Adverse Events(Immediately post-procedure, 2 days post procedure)
- Change in Work Ability Index (WAI) Work Productivity Loss(Baseline, 2 weeks, 2 months, 4 months)
- Change in Work Ability Index (WAI) Activity Impairment(Baseline, 2 weeks, 2 months, 4 months)
- Number of Participants With Major Adverse Events(Immediately post-procedure, 2 days post procedure)