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Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 65 and Older

This study is currently Recruiting

October 2011 By University of Washington

First Recieved on November 8, 2010

Last Updated on October 27, 2011

Sponsor: University of Washington
Collaborators: Kaiser Permanente
Information provided by: University of Washington
Identifier: NCT01238536

Purpose

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 Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:50 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Pain in the low back, buttock, and/or lower extremity (pain NRS>5) with standing, walking and/or spinal extension (buttock/leg>back pain). 2. Modified Roland-Morris score of at least 7. 3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan. 4. Lower extremity symptoms consistent with neurogenic claudication. 5. Must be able to read English and complete the assessment instruments. 6. Age 50 or older. Exclusion Criteria: 1. Cognitive impairment that renders the patient unable to give informed consent or provide accurate data. 2. 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 3. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months). 4. Spondylolisthesis requiring surgical fusion (i.e. greater than 5mm of slippage). 5. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis. 6. Metastatic cancer. 7. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use. 8. Possible pregnancy or other reason that precludes the use of fluoroscopy. 9. Concordant pain with internal rotation of the hip (or known hip joint pathology). 10. Active local or systemic infection. 11. Abnormal coagulation. 12. Allergy to local anesthetic, steroid or contrast. 13. Previous lumbar spine fusion surgery, X-STOP or lumbar decompression surgery. 14. Lumbar epidural steroid injection within previous 6 months.

Investigators

  • Investigator: Janna L Friedly, MD - Principal Investigator - University of Washington

Locations

  • Kaiser Permanente Northern California

    Redwood City, California 94063 United States

  • Kaiser Permanente Northern California

    Roseville, California 95661 United States

  • University of Colorado

    Denver, Colorado 80045 United States

  • Brigham and Women's Hospital

    Boston, Massachusetts 02467 United States

  • Henry Ford Hospital

    Detroit, Michigan 48202 United States

  • Mayo Clinic

    Rochester, Minnesota 55905 United States

  • Harborview Medical Center, University of Washington

    Seattle, Washington 98104 United States

Conditions related to this trial:

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