CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Dexamethasone Sodium Phosphate 10 MG/ML +4 moredrug
Likely dose
Transforaminal ESI with dexamethasone sodium phosphate 10 mg (1.5 mL of 10 mg/mL solution) and 1% lidocaine 1 mL, or interlaminar catheter ESI with triamcinolone acetonide 80 mg (2 mL of 40 mg/mL solution) and 1% lidocaine 1 mLAI-extracted
Key inclusion· 5
  • Age 18-80 years
  • Unilateral cervical radiculopathy C4-C8
  • MRI pathology consistent with symptoms
  • Pain severity NRS ≥4
Key exclusion· 8
  • Active infection
  • Bleeding disorders or current anticoagulant/antiplatelet use
  • Allergy to CESI medications
  • Pregnancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382821
NCT03382821Phase 4Completed

A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain

University of Utah·interventional·Posted Dec 26, 2017·Updated Nov 25, 2022

In Brief

A Phase 4 clinical trial evaluating Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone, and 3 other interventions for Cervical Radiculopathy. Completed, enrolled 120 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsEpimed

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartSep 15, 2017
Primary CompletionApr 15, 2020
Study CompletionAug 19, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.5 years ago

Interventions

Transforaminal ESI with dexamethasoneprocedure

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).

Transforaminal catheter-targeted ESI with triamcinoloneprocedure

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).

Dexamethasone Sodium Phosphate 10 MG/MLdrug

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

Lidocainedrug

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

Triamcinolone Acetonide 40mg/mLdrug

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