• Krishna Kumar, Richard North, Rod Taylor, Mark Sculpher, Carine Van den Abeele, Marta Gehring, Line Jacques, Sam Eldabe, Mario Meglio, Joan Molet, Simon Thomson, Jim O'Callaghan, Elon Eisenberg, Germain Milbouw, Gianpaolo Fortini, Jonathan Richardson, Eric Buchser, Sherri Tracey, Pascale Reny, Morag Brookes, Salvatore Sabene, Paola Cano, Carol Banks, Louise Pengelly, Rivka Adler, Sophie Leruth, Claire Kelly, and Myriam Jacobs.
• 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].
• Neuromodulation. 2005 Oct 1;8(4):213-8.

AbstractIntroduction.  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.

21 keywords...

hide…