CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 400 enrolled
Drug / intervention
Epidural steroid injection +3 moredrug
Likely dose
Epidural steroid injection 40 mgfrom 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/NCT01238536
NCT01238536Phase 4Completed
CompareCT.gov

Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older

University of Washington·interventional·Posted Nov 10, 2010·Updated Dec 13, 2017

In Brief

A Phase 4 clinical trial evaluating Epidural steroid with local anesthetic injection, Epidural local anesthetic injection, and 1 other intervention for Spinal Stenosis and Low Back Pain. Completed, enrolled 400 participants across 10 sites.

Detailed Summary

The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Stenosis, Low Back Pain
CountriesUnited States
CollaboratorsKaiser Permanente, University of California, San Francisco, Henry Ford Hospital, Harvard Pilgrim Health Care, Harvard Vanguard Medical Associates, University of Colorado, Denver, Mayo Clinic, Stanford University, Massachusetts General Hospital, Virginia Spine Research Institute, Oregon Health and Science University, Dallas VA Medical Center

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2010
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.6 years ago

Interventions

Epidural steroid with local anesthetic injectionprocedure

Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural local anesthetic injectionprocedure

Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.

Epidural steroid injectiondrug

Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.

Epidural local anesthetic injectiondrug

Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.