Phase 2 N=74 Randomized Double-blind Treatment

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

Cervicogenic Upper Extremity Radiculopathy

Bottom Line

View on ClinicalTrials.gov: NCT03389620 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2025

Primary outcome: Primary: Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours) — -3.38; -2.30 score on a scale — p=0.057

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dexamethasone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)	-2.51; -3.03; -3.44; -3.31	0.376
SECONDARY Change in Pain Numerical Rating Scale (Averaged Over Past 24 Hours)	-2.51; -3.03; -3.44; -3.31	0.376
SECONDARY Change in Neck Disability Index (NDI)	-10.97; -9.30; -10.24; -8.00; -14.25; -14.00	0.613
SECONDARY Change in EuroQol-5 Dimension (EQ-5D) Visual Analog Scale (VAS)	5.49; -0.38; 3.79; -1.03; 1.48; 2.69	0.287
SECONDARY Change in EuroQol-5 Dimension (EQ-5D) Index Score	0.085; 0.137; 0.088; 0.131; 0.145; 0.172	0.311
SECONDARY Change in Work Ability Index (WAI) Absenteeism	-11.76; -8.81; -13.66; -11.40; -9.09; -12.37	0.794
SECONDARY Change in Work Ability Index (WAI) Presenteeism	-8.95; -19.55; -8.95; -19.09; -26.50; -18.82	0.177
SECONDARY Change in Work Ability Index (WAI) Work Productivity Loss	-18.97; -20.79; -8.95; -19.09; -21.16; -26.37	0.811
SECONDARY Change in Work Ability Index (WAI) Activity Impairment	-13.51; -12.70; -9.12; -14.32; -18.18; -21.11	0.903
SECONDARY Number of Participants With Minor Adverse Events	3; 6; 4; 5	0.461
SECONDARY Number of Participants With Major Adverse Events	0; 0; 0; 0	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03389620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.