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A Corticosteroid Taper for Acute Sciatica Treatment (The ACT FAST Study)

This study is currently Recruiting

August 2011 By Kaiser Permanente

First Recieved on April 25, 2008

Last Updated on August 15, 2011

Sponsor: Kaiser Permanente
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: Kaiser Permanente
Identifier: NCT00668434

Purpose

Sciatica is a condition that causes a sharp, burning pain in the back, buttock, and leg. The condition is caused by injury to or compression of the sciatic nerve, which is located in the back of the leg. This study will determine the effectiveness of the steroid prednisone in decreasing pain and improving function in people with sciatica.

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

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville, CA site - Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution - Score of at least 20 on the modified Oswestry Disability Index - Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc - MRI study confirms a herniated disc consistent with the signs and symptoms Exclusion Criteria: - Onset of sciatica symptoms occurred more than 3 months before study entry - Cauda equina syndrome - Active cancer - Acute spinal fracture - Currently taking oral steroids - Diabetes mellitus and taking insulin or glycohemoglobin greater than 10% - Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg - Pregnant or breastfeeding - Active peptic ulcer disease - History of intolerance to steroid therapy - Bleeding diathesis or anticoagulant therapy - Ongoing litigation or workers compensation claim for low back pain or sciatica - Underwent previous lumbar surgery - Received epidural steroid injection (ESI) within the 12 months before study entry - Unable to read or speak English - Progressive or severe motor loss

Investigators

  • Investigator: Harley Goldberg, DO - Principal Investigator - Kaiser Permanente San Jose Medical Center
  • Investigator: Andrew L. Avins, MD, MPH - Principal Investigator - Kaiser Permanente Division of Research
  • Investigator: William Firtch, MD - Principal Investigator - Kaiser Permanente Redwood City
  • Investigator: Mark Tyburski, MD - Principal Investigator - Kaiser Permanente, Roseville, CA

Locations

  • Kaiser Permanente Northern California, Redwood City

    Redwood City, California 94063 United States

  • Kaiser Permanente

    Roseville, California 95661 United States

  • Kaiser Permanente Northern California, San Jose

    San Jose, California 94119 United States

Conditions related to this trial:

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