title: A new spinal cord stimulation system effectively relieves chronic, intractable pain: a multicenter prospective clinical study.
abstract: Objectives.  A prospective, open label, multicenter clinical trial confirmed the functionality of a new spinal cord stimulation (SCS) system for the treatment of chronic, intractable pain of the trunk and/or limbs. Materials and Methods.  Sixty-five subjects tested a rechargeable 16-channel SCS system with individual current control of each contact on one or two percutaneous eight-contact epidural leads. After baseline measurements, subjects were tracked on pain ratings and complication rates for up to 18 months. Results.  After a trial period, 75% of subjects underwent permanent implantation of the entire SCS system. More than one-half the implanted subjects experienced 50% or greater relief of pain after permanent implantation; some subjects reported relief of 90% or more of their pain. The most common complications after permanent implantation were lead migration, uncomfortable stimulation, and component failure; most resolved after reprogramming or device replacement. Conclusions.  The new SCS system provided good pain relief to a majority of subjects, and the results confirm a favorable safety and efficacy profile for the SCS system.
authors.affiliation: Yellowstone Neurosurgical Associates, Billings, MT, USA.              Pacific Pain Treatment Center, San Francisco, CA, USA;              California Pain Medicine Centers, Los Angeles, CA, USA;              North Shore University Hospital, Syosset, NY, USA;              Advanced Bionics/Boston Scientific, Valencia, CA, USA;              Dallas Neurosurgical Associates, Dallas, TX, USA;              Texas Back Institute, Plano, TX, USA; and              Stanford Medical Center, Stanford, CA, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Oakley
authors.forename: Elliot S
authors.initials: ES
authors.lastname: Krames
authors.forename: Joshua P
authors.initials: JP
authors.lastname: Prager
authors.forename: John
authors.initials: J
authors.lastname: Stamatos
authors.forename: Allison M
authors.initials: AM
authors.lastname: Foster
authors.forename: Richard
authors.initials: R
authors.lastname: Weiner
authors.forename: Ralph R
authors.initials: RR
authors.lastname: Rashbaum
authors.forename: Jaimie
authors.initials: J
authors.lastname: Henderson