NCT03389620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 5, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 19, 2025

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.5 years

First QC Date

December 26, 2017

Results QC Date

July 15, 2024

Last Update Submit

December 4, 2025

Conditions

Cervicogenic Upper Extremity Radiculopathy

Keywords

CT-fluoroscopyCorticosteroid injection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

  • Change in Work Ability Index (WAI) Absenteeism

    Baseline, 2 weeks, 2 months, 4 months

  • +5 more secondary outcomes

Other Outcomes (2)

  • 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

Study Arms (2)

Transforaminal Cervical Epidural Corticosteroid Injections

ACTIVE COMPARATOR
Drug: dexamethasone

Lateralized Interlaminar Epidural Corticosteroid Injections

EXPERIMENTAL
Drug: dexamethasone

Interventions

dexamethasoneDRUG

0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds

Lateralized Interlaminar Epidural Corticosteroid InjectionsTransforaminal Cervical Epidural Corticosteroid Injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Radiology and Orthopaedic Clinic

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Timothy J. Amrhein, M.D.
Organization
Duke University
timothy.amrhein@duke.edu
919-684-1909

Study Officials

  • Timothy Amrhein, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 3, 2018

Study Start

January 5, 2018

Primary Completion

July 16, 2023

Study Completion

September 16, 2023

Last Updated

December 19, 2025

Results First Posted

December 19, 2025

Record last verified: 2025-12

Locations

US(1)