Prueba clínica controlada de estimulación subcutánea para dolor lumbar por cirugía fallida de columna: el estudio SubQStim.: Artículo publicado en Neuromodulation 2018. Traducción Dr. Juan Carlos Andreani

Sam S. Eldabe; Rod S. Taylor; Stefaan Goossens; Benedic Bouche; Ismail Gultuna; Colin Green; Jennifer Tinsley; Pierre-Philippe Luyet; Eric Buchser

doi:10.47924/neurotarget201897

Autores/as

Sam S. Eldabe Department of Pain and Anaesthesia, The James Cook Hospital, Middlesbrough, UK.
Rod S. Taylor Institute of Health Research, University of Exeter Medical School, Exeter, UK.
Stefaan Goossens ZNA Middelheim, Antwerpen, Belgium.
Benedic Bouche CHU de Poitiers, Poitiers, France.
Ismail Gultuna Albert Schweitzer Ziekenhuis, Sliedrecht, The Netherlands.
Colin Green Institute of Health Research, University of Exeter Medical School, Exeter, UK.
Jennifer Tinsley Medtronic International Trading Sarl, Tolochenaz, Switzerland.
Pierre-Philippe Luyet Medtronic International Trading Sarl, Tolochenaz, Switzerland.
Eric Buchser EHC – H^opital de Morges, Morges, Switzerland.

DOI:

https://doi.org/10.47924/neurotarget201897

Palabras clave:

dolor lumbar, estimulación de nervio periférico, ensayo controlado aleatorizado, estimulación subcutánea, síndrome de la cirugía lumbar fallida

Resumen

Objetivos: Comparar la eficacia de la estimulación neural periférica utilizando la técnica de implante subcutánea Estimulación nerviosa subcutánea (codificada SQS) más el manejo médico óptimo (codificado SQS + OMM arm) vs manejo médico óptimo aislado (referente OMM) en pacientes con dolor lumbar debido a síndrome de cirugía falida de columna.
Pacientes y métodos: Los pacientes fueron reclutados desde 21 centros, en Europa, Israel, y Australia. Los pacientes seleccionados fueron aleatorizados a los grupos SQS + OMM o OMM, en proporción (1:1). Aquéllos del grupo SQS fueron implantados con un neuroestimulador y hasta dos electrodos cilíndricos percutáneos, en el área del dolor. Los pacientes fueron evaluados antes de su aleatorización, y a los uno, tres, seis y nueve meses luego de ella.
El punto final primario fue la proporción de sujetos con una reducción del 50% en la intensidad del dolor de espalda (“respondedor”) desde el inicio hasta los nueve meses.
Los resultados secundarios incluyeron la proporción de pacientes respondedores con una reducción del 50% en la intensidad del dolor de espalda a los seis meses y una reducción del 30% a los nueve meses, y el cambio medio desde el inicio en la intensidad del dolor de espalda a los seis y nueve meses entre los dos grupos. Resultados: Debido a la baja tasa de reclutamiento, el estudio finalizó temprano con 116 sujetos asignados al azar. Un total de 33,9% (19/56, ausente: n = 20 [36%]) de los sujetos en el brazo SQS + OMM y 1,7% (1/60, faltante: n = 24 [40%]) en el grupo OMM respondieron en el mes 9 (p <0.0001).
Los objetivos secundarios mostraron una diferencia significativa a favor del grupo SQS + OMM.
Conclusión: Los resultados indican que el agregado de SQS a OMM es más efectivo que OMM solamente, para aliviar el dolor lumbar hasta un seguimiento de nueve meses.

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