Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2015

Conditions
Spinal StenosisLow Back Pain
Interventions
PROCEDURE

Epidural steroid with local anesthetic injection

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.

PROCEDURE

Epidural local anesthetic injection

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

DRUG

Epidural steroid injection

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.

DRUG

Epidural local anesthetic injection

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

Trial Locations (10)

23235

Virginia Spine Research Institute, Richmond

48202

Henry Ford Hospital, Detroit

55905

Mayo Clinic, Rochester

75216

Dallas VA Medical Center, Dallas

80045

University of Colorado, Denver

94063

Kaiser Permanente Northern California, Redwood City

95661

Kaiser Permanente Northern California, Roseville

98104

Harborview Medical Center, University of Washington, Seattle

02467

Brigham and Women's Hospital, Boston

Unknown

Oregon Health and Science University, Portland

Sponsors
All Listed Sponsors
collaborator

Kaiser Permanente

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

Henry Ford Hospital

OTHER

collaborator

Harvard Pilgrim Health Care

OTHER

collaborator

Harvard Vanguard Medical Associates

OTHER

collaborator

University of Colorado, Denver

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

Stanford University

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

Virginia Spine Research Institute

UNKNOWN

collaborator

Oregon Health and Science University

OTHER

collaborator

Dallas VA Medical Center

FED

lead

University of Washington

OTHER