Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

Phase 2

Completed

• Conditions: Cervicogenic Upper Extremity Radiculopathy
• Interventions: Drug: dexamethasone

• Registration Number: NCT03389620
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-03
• Study Start: 2018-01-05
• Primary Completion: 2023-07-16
• Study Completion: 2023-09-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transforaminal Cervical Epidural Corticosteroid Injections	dexamethasone	-
Lateralized Interlaminar Epidural Corticosteroid Injections	dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (averaged over past 24 hours)	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 Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	4 months	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.
Change in Neck Disability Index (NDI)	Baseline, 2 weeks, 2 months, 4 months	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.
NRS (averaged over past 24 hours)	4 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")
Change in NRS (averaged over past 24 hours)	Baseline, 2 weeks, 2 months, 4 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")
EQ-5D at 2 weeks	2 weeks	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.
EQ-5D at 2 months	2 months	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.
EQ-5D at 4 months	4 months	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.
Frequency of minor Adverse Events	2 days post procedure
Frequency of contrast spread into the neuroforamen for each group	During procedure
Rate of inadvertent intravascular contrast injections	During procedure
Change in EQ-5D	Baseline, 2 weeks, 2 months, 4 months	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.
Work Ability Index at 2 weeks	2 weeks	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.
Work Ability Index at 4 months	4 months	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.
Work Ability Index at 2 months	2 months	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.
Change in Work Ability Index	2 week, 3 months, 4 months	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.
Frequency of major Adverse Events	2 days post procedure

Trial Locations

Locations (1)

Duke Radiology and Orthopaedic Clinic; 🇺🇸 Durham, North Carolina, United States