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A2005: Evidence – Spinal Cord Stimulation with Precision® SCS System versus Reoperation for Failed Back Surgery Syndrome

Dr. William Taylor, Dr. Nicholas Kormylo and their associates are conducting a research study sponsored by Boston Scientific Corporation (BSC) to compare surgery to the Precision® Spinal Cord Stimulation (SCS) system to relieve chronic pain from “Failed Back Surgery Syndrome”. The Precision system has already been approved by the United States Food and Drug Administration (FDA), Health Canada and the European Union Notified Bodies for the treatment of chronic, intractable pain of the back, arm or legs. Your participation in this study will help compare the treatment and cost-effectiveness of SCS versus reoperation for patients with Failed Back Surgery Syndrome.

Eligible volunteers:

1. At least 18 years of age
2. Recommended by Drs. Taylor and/or Kormylo
3. Chief complaint of persistent or recurrent radicular leg pain (pain originating from the low back and traveling down the leg), with or without low back pain, or 50% leg pain and 50% low back pain after one or more lumbosacral (low back) surgical procedures
4. Leg pain duration of at least 6 months

Not eligible:

1. Chief complaint of low back pain (greater than 50% of pain)
2. Leg pain intensity always 10 on a scale of 1 to 10 over the past 6 months
3. A significant or disabling chronic pain problem or condition other than leg /back pain, that is likely to interfere with the evaluation of the leg and/or back pain
4. Pregnancy (actual or planned)
5. Prior Spinal Cord Stimulation (SCS) procedure
6. Presence of intrathecal drug pump to treat leg and/or back pain
7. Medical or cardiac conditions, or foreseeable need for therapies or diagnostic tests (e.g., MRI), that preclude SCS and/or reoperation

For more information, please contact:

Michael G. Beainy
Clinical Trials Operations Manager, Pain Research
Staff Research Associate IV
University of California, San Diego Medical Center
Center for Pain Medicine
Tel.  858-657-7039 ext.77039
mbeainy@ucsd.edu