title: Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study).
abstract: Introduction.  Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re-operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost-effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS. Methods/Design.  A total of 100 FBSS patients with predominantly neuropathic leg pain will be recruited from 12 centers and randomized to receive either conventional medical management alone or in combination with SCS for a period of 24 months. Patients will be evaluated at 1, 3, 6, 9, 12, 18, and 24 months. At the 6-month visit, patients will be classified as successful (≥  50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm. Discussion.  This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost-effectiveness of an SCS system in patients with FBSS.
authors.affiliation: Department of Neurosurgery Regina General Hospital, Regina, Saskatchewan, Canada;              Johns Hopkins University School of Medicine, Baltimore, Maryland, USA;              Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham, UK;              Centre for Health Economics, University of York, York, UK;              Medtronic Europe Sàrl, Route de Molliau, Tolochenaz, Switzerland;              Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada;              Department of Pain & Anaesthesia, James Cook University Hospital, Middlesbrough, Cleveland, UK;              Institute of Neurosurgery, Catholic University of Rome, Rome, Italy;              Department of Neurosurgery, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain;              Pain Management Clinic, Basildon and Thurrock University Hospitals, Basildon, Essex, UK;              Pain Clinic, Axxon Pain Medicine, Brisbane, Queensland, Australia;              Pain Relief Unit, Rambam Medical Center, Haifa, Israel;              Department of Neurosurgery, Centre Hospitalier Régional de Namur (CHR Namur), Namur, Belgium;              Pain Management Department, Varese Regional Hospital and Macchi Foundation, Varese, Italy;              Department of Pain and Anesthesia, Bradford Hospitals, Bradford, UK; and              Anesthesia and Pain Management Services, Center for Neuromodulation EHC, Hospital of Morges, Morges, Switzerland, [ISRCTN77527324].
authors.forename: Krishna
authors.initials: K
authors.lastname: Kumar
authors.forename: Richard
authors.initials: R
authors.lastname: North
authors.forename: Rod
authors.initials: R
authors.lastname: Taylor
authors.forename: Mark
authors.initials: M
authors.lastname: Sculpher
authors.forename: Carine
authors.initials: C
authors.lastname: Van den Abeele
authors.forename: Marta
authors.initials: M
authors.lastname: Gehring
authors.forename: Line
authors.initials: L
authors.lastname: Jacques
authors.forename: Sam
authors.initials: S
authors.lastname: Eldabe
authors.forename: Mario
authors.initials: M
authors.lastname: Meglio
authors.forename: Joan
authors.initials: J
authors.lastname: Molet
authors.forename: Simon
authors.initials: S
authors.lastname: Thomson
authors.forename: Jim
authors.initials: J
authors.lastname: O'Callaghan
authors.forename: Elon
authors.initials: E
authors.lastname: Eisenberg
authors.forename: Germain
authors.initials: G
authors.lastname: Milbouw
authors.forename: Gianpaolo
authors.initials: G
authors.lastname: Fortini
authors.forename: Jonathan
authors.initials: J
authors.lastname: Richardson
authors.forename: Eric
authors.initials: E
authors.lastname: Buchser
authors.forename: Sherri
authors.initials: S
authors.lastname: Tracey
authors.forename: Pascale
authors.initials: P
authors.lastname: Reny
authors.forename: Morag
authors.initials: M
authors.lastname: Brookes
authors.forename: Salvatore
authors.initials: S
authors.lastname: Sabene
authors.forename: Paola
authors.initials: P
authors.lastname: Cano
authors.forename: Carol
authors.initials: C
authors.lastname: Banks
authors.forename: Louise
authors.initials: L
authors.lastname: Pengelly
authors.forename: Rivka
authors.initials: R
authors.lastname: Adler
authors.forename: Sophie
authors.initials: S
authors.lastname: Leruth
authors.forename: Claire
authors.initials: C
authors.lastname: Kelly
authors.forename: Myriam
authors.initials: M
authors.lastname: Jacobs