Estimulación de la Médula Espinal Versus Tratamiento Médico Convencional para el Dolor Neuropático: Un Ensayo Multicéntrico Randomizado Controlado en Pacientes con Síndrome de Cirugía Fallida de Columna: Publicado Originalmente en la Revista PAIN 132 (2007) 179–188

Krishna Kumar; Rod S. Taylor; Line Jacques; Sam Eldabe; Mario Meglio; Joan Molet; Simon Thomson; Jim O’callaghan; Elon Eisenberg; Germain Milbouw; Eric Buchser; Gianpaolo Fortini; Jonathan Richardson; Richard B. North

doi:10.47924/neurotarget2011292

Authors

Krishna Kumar Department of Neurosurgery, Regina General Hospital, Canada.
Rod S. Taylor Península Medical School, University of Exeter, UK.
Line Jacques Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Canada.
Sam Eldabe Department of Pain and Anesthesia, James Cook University Hospital, Middlesbrough, UK.
Mario Meglio Department of Functional Neurosurgery, Gemelli Catholic University Hospital, Rome, Italy.
Joan Molet Department of Neurosurgery, Santa Creu i Sant Pau Hospital, Barcelona, Spain.
Simon Thomson Pain Clinic, Basildon and Thurrock University Hospitals, Basildon, UK.
Jim O’callaghan Pain Clinic, Axxon Pain Medicine, Brisbane, Australia.
Elon Eisenberg Pain Relief Unit, Rambam Medical Center, Haifa, Israel.
Germain Milbouw Neurosurgery, Namur Regional Hospital, Namur, Belgium.
Eric Buchser Pain Clinic, Morges Hospital, Morges, Switzerland.
Gianpaolo Fortini Pain Clinic, Varese Regional Hospital and Macchi Foundation, Varese, Italy.
Jonathan Richardson Department of Pain and Anesthesia, Bradford Hospitals, Bradford, UK.
Richard B. North Department of Neurosurgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.

DOI:

https://doi.org/10.47924/neurotarget2011292

Keywords:

Spinal cord stimulation, Neurostimulation, Neuropathic pain, Failed back surgery syndrome, Radicular pain, Randomised controlled study

Abstract

Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health-related quality of life, functional capacity, use of pain medication and non- drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6-months visit was permitted, and all patients were followed up to 1 year. In the intention-to-treat analysis at 6 months, 24 SCS patients (48%) and 4CMMpatients (9%) (p < 0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p ≤ 6 0.05 for all comparisons). Between 6 and 12 months, 5 SCS patients crossed to CMM, and 32 CMM patients crossed to SCS. At 12 months, 27 SCS patients (32%) had experienced device- related complications. In selected patients with FBSS, SCS provides better pain relief and improves health-related quality of life and functional capacity compared with CMM alone.

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