Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

Comparison of Cervical Transforaminal Epidural Corticosteroid Injections With Lateralized Interlaminar Epidural Corticosteroid Injections for Treatment of Cervicogenic Upper Extremity Radiculopathy

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 Overview

• Status: Completed
• Conditions: Cervicogenic Upper Extremity Radiculopathy
• Intervention / Treatment: Drug: dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Radiology and Orthopaedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transforaminal Cervical Epidural Corticosteroid Injections	Drug: dexamethasone; 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
Experimental: Lateralized Interlaminar Epidural Corticosteroid Injections	Drug: dexamethasone; 0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)	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")	Baseline to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neck Disability Index (NDI)	The NDI a well-validated measurement tool that contains 10 items: seven related to activities of daily living, two related to pain, and one related to concentration. Each item is scored from 0 to 5 and the total score is expressed as a percentage, with higher scores corresponding to greater disability.	Baseline, 2 weeks, 2 months, 4 months
Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)	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")	Baseline, 2 weeks, 4 months
Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)	EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).	Baseline, 2 weeks, 2 months, 4 months
Change in EuroQol-5 Dimension (EQ-5D) Index Score	EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It is a well-validated tool for health status measurement, and for health quality-of-life in cervicogenic radicular pain. The index score was derived using the time trade-off (TTO) valuation method and ranges from approximately 0 (dead) to 1 (full health), with negative values indicating health states worse than death.	Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Absenteeism	The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.	Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Presenteeism	The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.	Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Work Productivity Loss	The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.	Baseline, 2 weeks, 2 months, 4 months
Change in Work Ability Index (WAI) Activity Impairment	The Work Ability Index (WAI) is a validated, reliable measure of a worker's ability to do his or her job that has been shown to predict work disability, retirement and mortality. The WAI is scored on a scale of 7 to 49, where higher scores indicate better work ability.	Baseline, 2 weeks, 2 months, 4 months
Number of Participants With Minor Adverse Events		Immediately post-procedure, 2 days post procedure
Number of Participants With Major Adverse Events		Immediately post-procedure, 2 days post procedure

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Inadvertent Intravascular Contrast Injections	During procedure
Number of Participants With Contrast Spread Into the Medial Half of the Neuroforamen	During procedure

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Timothy Amrhein, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): July 16, 2023
• Study Completion (Actual): September 16, 2023

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CT-fluoroscopy; Corticosteroid injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone
• Other Study ID Numbers: Pro00083262

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No