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

Authors

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

Keywords:

Back pain, failed back surgery syndrome, peripheral nerve field stimulation, randomized controlled trial, subcutaneous stimulation

Abstract

Objectives: To compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique— subcutaneous nerve stimulation (SQS) plus optimized medical management (SQS1OMM arm) vs. optimized medical management alone (OMM arm) in patients with back pain due to failed back surgery syndrome.
Patients and Methods: Patients were recruited from 21 centers, in Europe, Israel, and Australia. Eligible patients were randomized (1:1) to SQS1OMM or OMM arms. Those in the SQS arm were implanted with a neurostimulator and up to two subcutaneous percutaneous cylindrical leads in the area of pain. Patients were evaluated pre-randomization and at one, three, six, and nine months post-randomization. The primary endpoint was the proportion of subjects with a 50% reduction in back pain intensity (“responder”) from baseline to nine months. Secondary outcomes included proportion of responders with a 50% reduction in back pain intensity at six months and 30% reduction at nine months, and the mean change from baseline in back pain intensity at six and nine months between the two arms.
Results: Due to the slow rate of recruitment, the study was terminated early with 116 subjects randomized. A total of 33.9% (19/56, missing: n520 [36%]) of subjects in the SQS1OMM arm and 1.7% (1/60, missing: n524 [40%]) in the OMM arm were responders at Month 9 (p<0.0001). Secondary objectives showed a significant difference in favor of SQS1OMM arm.
Conclusion: The results indicate that the addition of SQS to OMM is more effective than OMM alone in relieving low back pain at up to nine months.

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