CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
Transforaminal epidural compound betamethasone injection +3 moredrug
Likely dose
Transforaminal epidural compound betamethasone injection 1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03101033
NCT03101033N/ACompleted

Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc:A Single Center, Controlled Clinical Trial

yan lu·interventional·Posted Apr 4, 2017·Updated Sep 4, 2018

In Brief

A clinical study evaluating Mechanical epidural neuroplasty, Transforaminal epidural compound betamethasone injection, and 2 other interventions for Herniated Lumbar Disc. Completed, enrolled 92 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 4, 2017
Enrollment StartMay 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago

Interventions

Mechanical epidural neuroplastydevice

Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter (BS epidural catheter, BioSpine Co., Ltd, Korea) will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.

Transforaminal epidural compound betamethasone injectiondrug

Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.

Caudal epidural compound betamethasone injectiondrug

steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.

Epidural hyaluronidase injectiondrug

Hyaluronidase of 1500 IU (Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD)will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.