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Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

NCT03382821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-11-25

Study results available
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Summary

Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?

Conditions

  • Cervical Radiculopathy

Interventions

PROCEDURE

Transforaminal ESI with dexamethasone

Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).

PROCEDURE

Transforaminal catheter-targeted ESI with triamcinolone

Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).

DRUG

Dexamethasone Sodium Phosphate 10 MG/ML

Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1

DRUG

Lidocaine

1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2

DRUG

Triamcinolone Acetonide 40mg/mL

Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2

Sponsors & Collaborators

Principal Investigators

  • Zachary L McCormick, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2020-04-15
Completion
2020-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03382821 on ClinicalTrials.gov