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

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.

Conditions

• Spinal Stenosis
• Low 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.

Sponsors & Collaborators

• Kaiser Permanente

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Henry Ford Hospital

  collaborator OTHER

• Harvard Pilgrim Health Care

  collaborator OTHER

• Harvard Vanguard Medical Associates

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Virginia Spine Research Institute

  collaborator UNKNOWN

• Oregon Health and Science University

  collaborator OTHER

• Dallas VA Medical Center

  collaborator FED

• University of Washington

  lead OTHER

Principal Investigators

• Janna L Friedly, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2013-08-31

Completion

2015-09-30

Countries

• United States

Study Locations