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

Completed · Phase 4

Conditions studied: Spinal Stenosis, Low Back Pain

In brief

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.

Key facts

Study ID

NCT01238536

Run by

University of Washington

People needed

400

Starts

2011-04-01

Expected to finish

2015-09-01

Last updated by the study team

2017-12-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).
• Modified Roland-Morris score of at least 7.
• Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.
• Lower extremity symptoms consistent with neurogenic claudication.
• Must be able to read English and complete the assessment instruments.
• Age 50 or older.

You may not qualify if…

• Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.
• Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
• Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury, dementia, stroke, other neurologic conditions Collect date about cervical spinal stenosis, painful peripheral neuropathy, EMGs
• Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).
• Spinal instability requiring surgical fusion.
• Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
• Metastatic cancer.
• Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
• Possible pregnancy or other reason that precludes the use of fluoroscopy.
• Concordant pain with internal rotation of the hip (or known hip joint pathology).
• Active local or systemic infection.
• Abnormal coagulation.
• Allergy to local anesthetic, steroid or contrast.
• Previous lumbar spine surgery.
• Epidural steroid injection within previous 6 months.

Where it is running

• Kaiser Permanente Northern California — Redwood City, California, United States
• Kaiser Permanente Northern California — Roseville, California, United States
• University of Colorado — Denver, Colorado, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• Virginia Spine Research Institute — Richmond, Virginia, United States
• Harborview Medical Center, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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