Spinal cord stimulation vs. conventional medical management: A prospective, randomized, controlled, multicenter study of patients with failed back surgery syndrome (PROCESS study)

Neuromodulation

Volumn 8, Issue 4, 2005, Pages 213-218

  Kumar, Krishna ^a   North, Richard ^b   Taylor, Rod ^c   Sculpher, Mark ^d   Van Den Abeele, Carine ^e   Gehring, Marta ^e   Jacques, Line ^f   Eldabe, Sam ^g   Meglio, Mario ^h   Molet, Joan ⁱ   Thomson, Simon ^j   O'Callaghan, Jim ^k   Eisenberg, Elon ^l   Milbouw, Germain ^m   Fortini, Gianpaolo ⁿ   Richardson, Jonathan ^o   Buchser, Eric ^p   Tracey, Sherri ^a   Reny, Pascale ^f   Brookes, Morag ^g   Sabene, Salvatore ^h   Cano, Paola ⁱ   Banks, Carol ^j   Pengelly, Louise ^k   Adler, Rivka ^l   Leruth, Sophie ^m   Kelly, Claire ^o   Jacobs, Myriam ^p   more..

^a REGINA GENERAL HOSPITAL   (Canada)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^d UNIVERSITY OF YORK   (United Kingdom)

^e Medtronic Europe Sàrl ^*  (Switzerland)

^f MCGILL UNIVERSITY   (Canada)

^g JAMES COOK UNIVERSITY HOSPITAL   (United Kingdom)

^h CATHOLIC UNIVERSITY   (Italy)

ⁱ HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^j BASILDON HOSPITAL   (United Kingdom)

^k Pain Clinic   (Australia)

^l RAMBAM MEDICAL CENTER   (Israel)

^m Centre Hospitalier Regional de Namur   (Belgium)

ⁿ OSPEDALE DI CIRCOLO   (Italy)

^o Bradford Hospitals   (United Kingdom)

^p Hospital of Morges   (Switzerland)

more..

Author keywords

Dorsal column stimulation; Failed back surgery syndrome; Neuropathic pain; Spinal cord stimulation

Indexed keywords

ARTICLE; BACKACHE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; FAILED BACK SURGERY SYNDROME; HEALTH CARE COST; HUMAN; LEG PAIN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NEUROPATHIC PAIN; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL; SPINAL CORD STIMULATION; SYNDROME;

EID: 33745375771     PISSN: 10947159     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1525-1403.2005.00027.x     Document Type: Article

References (24)

1. Augustinsson LE Carlsson CA Holm J Jivegard L. Epidural electrical stimulation in severe limb ischaemia. Pain relief, increased blood flow, and a possible limb-saving effect. Ann Surg 1985 202: 104 110.
2. Barolat-Romana G Myklebust JB Hemmy CD Myklebust B Wenninger W. Immediate effects of spinal cord stimulation in spinal spasticity. J Neurosurg 1985 62: 558 562.
3. Sanderson JE Brooksby P Waterhouse D Palmer RB Neubauer K. Epidural spinal electrical stimulation for severe angina. A study of its effects on symptoms, exercise tolerance and degree of ischaemia. Eur Heart J 1992 13: 628 633.
4. Burchiel K Anderson V Braun FD et al. Prospective, multicenter study of spinal cord stimulation for relief of chronic back and extremity pain. Spine 1996 21: 2786 2794.
5. Barolat G Oakley J Law JD North RB Ketcik B Sharan A. Epidural spinal cord stimulation with a multiple electrode paddle lead is effective in treating intractable low back pain. Neuromodulation 2001 4: 59 66.
6. Leveque J-C Villavicencio AT Bulsara KR Rubin L Gorecki JP. Spinal cord stimulation for failed back surgery syndrome. Neuromodulation 2001 4: 1 9.
7. Kumar K Nath R Toth C. Spinal cord stimulation is effective in the management of reflex sympathetic dystrophy. Neurosurgery 1997 40: 503 509.
8. Van Buyten JP Van Zundert J Vueghs P Vanduffel L. Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium. Eur J Pain 2001 5: 299 307.
9. Kemler MA Barebdse GA Van Kleef M et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med 2000 343: 618 624.
10. Melzack R Wall PD. Pain mechanisms: a new theory. Science 1965 150: 971 979.
11. North RB Kidd DH Lee MS Piantodosi S. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome. Stereotact Funct Neurosurg 1994 62: 267 272.
12. North R Kidd D Farrokhi F Piantodosi S. Spinal cord stimulation versus repeated lumbosacral surgery for chronic, intractable pain: a randomized, controlled trial. Neurosurgery 2005 56: 98 107.
13. Turner JA Loeser JD Deyo RA Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004 108: 137 147.
14. Taylor RS Van Buyten JP Buchser E. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: a systematic review and analysis of prognostic factors. Spine 2005 30: 152 160.
15. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review. J Neurosurgery 2004 100: 254 267.
16. Carter ML. Spinal cord stimulation in chronic pain: a review of the evidence. Anaesth Intensive Care 2004 32: 11 21.
17. Kind P. The EuroQoL instrument. an index of health-related quality of life. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. 2nd ed, Philadelphia: Lippincott-Raven 1996, 191 201.
18. Efron B Tibshirani R. An introduction to the bootstrap. New York: Chapman & Hall, 1993: 456 p.
19. Fenwiock E O'Brien BJ Briggs A. Cost-effectiveness acceptability curves - facts, fallacies and frequently asked questions. Health Econ 2004 13: 405 415.
20. Taylor RJ Taylor RS. Spinal cord stimulation for failed back surgery syndrome: a decision analytic model and costs effectiveness analysis. Int J Technol Assess Health Care 2005 21: 351 358.
21. National Institute for Clinical Excellence (NICE). The guideline development process - An overview for stakeholders, the public and the NHS. February 2004. http://www.nice.org.uk.
22. Ong KS Seymour RA. Pain measurements in humans. Surgeon 2004 2: 15 27.
23. Farrar JT Young JP LaMoreaux L Werth JL Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001 94: 149 158.
24. European Medicine Evaluation Agency (EMEA). Guidelines on clinical investigation of medicinal products for the treatment of neuropathic pain. November 2004.