Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study)

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Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study)
Issue online:
13 Oct 2005
To cite this article: Krishna Kumar MD, FRCSC, Richard North MD, Rod Taylor PhD, Mark Sculpher PhD, Carine Van den Abeele BA, Marta Gehring BA, Line Jacques MD, FRCSC, Sam Eldabe MB, ChB, FRCA, Mario Meglio MD, Joan Molet MD, PhD, Simon Thomson MBBS, FRCA, Jim O'Callaghan MBBS, Elon Eisenberg MD, Germain Milbouw MD, PhD, Gianpaolo Fortini MD, PhD, Jonathan Richardson MD, FRCA, Eric Buchser MD, DEAA, Sherri Tracey RN, Pascale Reny RN, MSc, Morag Brookes RGN, BSc, Salvatore Sabene RN, Paola Cano MD, Carol Banks MSc, Louise Pengelly RN, Rivka Adler RN, Sophie Leruth RN, (2005)
Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study)
Neuromodulation 8 (4), 213Ň218.
Blackwell Synergy

Krishna Kumar, MD, FRCSC**Department of Neurosurgery Regina General Hospital, Regina, Saskatchewan, Canada; Richard North, MDJohns Hopkins University School of Medicine, Baltimore, Maryland, USA; Rod Taylor, PhDDepartment of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham, UK; Mark Sculpher, PhD??Centre for Health Economics, University of York, York, UK; Carine Van den Abeele, BA??Medtronic Europe Sárl, Route de Molliau, Tolochenaz, Switzerland; Marta Gehring, BA??Medtronic Europe Sárl, Route de Molliau, Tolochenaz, Switzerland; Line Jacques, MD, FRCSC****Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada; Sam Eldabe, MB, ChB, FRCADepartment of Pain & Anaesthesia, James Cook University Hospital, Middlesbrough, Cleveland, UK; Mario Meglio, MDInstitute of Neurosurgery, Catholic University of Rome, Rome, Italy; Joan Molet, MD, PhD????Department of Neurosurgery, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain; Simon Thomson, MBBS, FRCA????Pain Management Clinic, Basildon and Thurrock University Hospitals, Basildon, Essex, UK; Jim O'Callaghan, MBBS******Pain Clinic, Axxon Pain Medicine, Brisbane, Queensland, Australia; Elon Eisenberg, MDPain Relief Unit, Rambam Medical Center, Haifa, Israel; Germain Milbouw, MD, PhDDepartment of Neurosurgery, Centre Hospitalier R»gional de Namur (CHR Namur), Namur, Belgium; Gianpaolo Fortini, MD, PhD??????Pain Management Department, Varese Regional Hospital and Macchi Foundation, Varese, Italy; Jonathan Richardson, MD, FRCA??????Department of Pain and Anesthesia, Bradford Hospitals, Bradford, UK; and Eric Buchser, MD, DEAA********Anesthesia and Pain Management Services, Center for Neuromodulation EHC, Hospital of Morges, Morges, Switzerland, [ISRCTN77527324] Sherri Tracey, RN**Department of Neurosurgery Regina General Hospital, Regina, Saskatchewan, Canada; Pascale Reny, RN, MSc****Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada; Morag Brookes, RGN, BScDepartment of Pain & Anaesthesia, James Cook University Hospital, Middlesbrough, Cleveland, UK; Salvatore Sabene, RNInstitute of Neurosurgery, Catholic University of Rome, Rome, Italy; Paola Cano, MD????Department of Neurosurgery, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain; Carol Banks, MSc????Pain Management Clinic, Basildon and Thurrock University Hospitals, Basildon, Essex, UK; Louise Pengelly, RN******Pain Clinic, Axxon Pain Medicine, Brisbane, Queensland, Australia; Rivka Adler, RNPain Relief Unit, Rambam Medical Center, Haifa, Israel; Sophie Leruth, RNDepartment of Neurosurgery, Centre Hospitalier R»gional de Namur (CHR Namur), Namur, Belgium; Claire Kelly, RN??????Department of Pain and Anesthesia, Bradford Hospitals, Bradford, UK; and Myriam Jacobs, RN****

Acknowledgments: PROCESS Study Investigators. Sponsor: Medtronic, Inc. Dr Kumar is a consultant for Medtronic.

Competing Interests: Dr Buchser, Dr Taylor, Dr North, and Dr Sculpher are consultants for Medtronic Europe Sárl on this and/or other projects.

Address correspondence and reprint requests to: Krishna Kumar, Regina General Hospital, Regina, Saskatchewan, Canada. Email: krishna.kumar@rqhealth.ca
Key Words: dorsal column stimulation, neuropathic pain, spinal cord stimulation, failed back surgery syndrome

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 (&#8805; 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.

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