Presented at the 2013 AAPM Annual Meeting « Back

Spinal Cord Stimulation for Predominant Low Back Pain in Failed Back Surgery Syndrome: Design of an International Multicenter Randomized Controlled Trial (PROMISE Study)

Mehul J. Desai, MD MPH, mdesai@mfa.gwu.edu¹, Philippe Rigoard, MD PhD², Richard North, MD³, Rod Taylor, MSc PhD⁴, Lieven Annemans⁵, Christine Osborne, MS⁶, Ye Tan, MS7⁶, Carine Van Den Abeele, BA⁷, Jane Shipley⁸, Krishna Kumar, MD⁹, (1) GW Spine & Pain Center, Washington, D.C., (2) philipperigoard@yahoo.fr, University Poitiers Hospital, 86000 Poitiers, France, (3) Berman Brain & Spine Institute, Baltimore, Maryland, (4) Exeter Medical School, Exeter, England, United Kingdom, (5) Ghent University, Brussels, Belgium (6) Medtronic, Inc., Minneapolis, Minnesota, (7) Medtronic International Trading, Tolochenaz, Vaud, Switzerland, (8) The Neuromodulation Foundation, Inc., Baltimore, Maryland, (9) Regina General Hospital, Regina, Saskatchewan, Canada

Introduction: Randomized controlled trials (RCT) have shown spinal cord stimulation (SCS) to be effective for failed back surgery syndrome (FBSS) patients with radicular pain, but we lack RCT data for low back pain. The PROMISE RCT will compare SCS plus optimal medical management (OMM) versus OMM alone in FBSS patients with predominant low back pain. Materials and Methods: In accord with an IRB/EC-approved protocol, subjects with predominant low back pain will be recruited in approximately 30 centers in Canada, Europe, and the United States for 1:1 randomization to SCS + OMM or OMM alone. Each individualized OMM treatment plan will exclude intrathecal drug delivery, peripheral nerve stimulation, back surgery related to original pain, and experimental therapies. SCS subjects who pass trial stimulation will receive a neurostimulation system using a multicolumn surgical lead. Evaluations will occur at 1, 3, 6, 9, 12, 18, and 24 months post-randomization. The primary outcome will be an intention-to-treat analysis of the percent of subjects with ≥50% reduction in low back pain at 6 months, when subjects may change treatment groups. Additional outcomes will be changes in low back and leg pain, functional capacity, and quality of life as well as patient satisfaction. Health care utilization data will support a cost consequences analysis and development of a long-term economic model. Results: Study enrollment will start in 2012. Conclusion: PROMISE will provide evidence of the effectiveness of SCS using a multicolumn array for predominant low back pain in FBSS. References: 1) Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB: Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicenter randomized controlled tiral in patients with failed back surgery syndrome. Pain. 2007 Nov;132(1-2);179-88. 2) North RB, Kidd DH, Farrokhi F, Piantadosi S: Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: A randomized, controlled trial. Neurosurgery 56:98-106; discussion 106-107, 2005.

Funding: Design and Implementation of Clinical Trial, Medtronic, Inc.