278
Participants
Start Date
January 8, 2013
Primary Completion Date
March 12, 2016
Study Completion Date
June 20, 2017
Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
UCL St. Luc, Brussels
AZ St. Maarten, Duffel
Department of Neurosurgery: St. Augustinus Ziekenhuizen, Wilrijk
CHR Citadelle, Liège
Heilig Hart Ziekenhuis, Roeselare
Albany Medical College, Albany
New York Spine and Wellness Center, North Syracuse
University of Rochester Neurosurgery Partners in Pain Management, Rochester
WellSpan Interventional Pain Center, York
West Virginia University, Morgantown
Duke Spine Center, Durham
Pain Care LLC, Stockbridge
The Neuroscience Center, Ocean Springs
Hospital Clinico Universitario de Valencia, Valencia
Hospital Clínico Universitario de Valladolid, Valladolid
Richmond Bone and Joint Clinic, Sugar Land
Utah Spine Care, Ogden
Centre Hospitalier Universitaire de Poitiers, Poitiers
Kozmary Center for Pain Management, Las Vegas
Weill Medical College of Cornell University, New York
Regina General Hospital, Regina
Clínica Las Américas, Medellín
Hospital Pablo Tobón Uribe, Medellín
San Vicente Fundación, Rionegro
Städtisches Klinikum Görlitz gGmbH, Görlitz
St. Elisabeth Ziekenhuis Tilburg, Tilburg
Nottingham University Hospital NHS Trust, Nottingham
John Radcliffe Hospital Oxford, Oxford
Lead Sponsor
MedtronicNeuro
INDUSTRY