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While spinal cord stimulation (SCS) is a well-established therapy to address refractory persistent spinal pain syndrome after spinal surgery (PSPS-T2), its lack of spatial selectivity and reported discomfort due to positional effects can be considered as significant limitations. As alternatives, new waveforms, such as burst stimulation and different spatial neural targets, such as dorsal root ganglion stimulation (DRGS), have shown promising results. Comparisons between DRGS and standard SCS, or their combination, have never been studied on the same patients. “BOOST DRG” is the first prospective, randomized, double-blinded, crossover study to compare SCS vs. DRGS vs. SCS+DRGS. Sixty-six PSPS-T2 patients will be recruited internationally in three centers. Before crossing over, patients will receive each stimulation modality for 1 month, using tonic conventional stimulation. After 3 months, stimulation will consist in switching to burst for 1 month, and patients will choose which modality/waveform they receive and will then be reassessed at 6 and 12 months. In addition to our primary outcome based on pain rating, this study is designed to assess quality of life, functional disability, psychological distress, pain surface coverage, global impression of change, medication quantification, adverse events, brain functional imaging and electroencephalography, with the objective being to provide a multidimensional insight based on composite pain assessment.
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; Adjali, Nihel 2 ; Ounajim, Amine 2
; Voirin, Jimmy 4 ; Perruchoud, Christophe 5 ; Bouche, Bénédicte 6 ; Page, Philippe 7 ; Guillevin, Rémy 8 ; Naudin, Mathieu 8 ; Simoneau, Martin 9 ; Lorgeoux, Bertille 2 ; Baron, Sandrine 2 ; Nivole, Kevin 2 ; Many, Mathilde 2 ; Maitre, Iona 2 ; Rigoard, Raphaël 10 ; Romain, David 11 ; Moens, Maarten 3 ; Billot, Maxime 2
1 PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France;
2 PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France;
3 Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium;
4 Department of Neurosurgery, Hopitaux Civils de Colmar, 68000 Colmar, France;
5 Service of Anesthesiology and Pain Centre, University Hospital of Lausanne (CHUV), 1011 Lausanne, Switzerland;
6 PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France;
7 Department of Spine Surgery & Neuromodulation, Poitiers University Hospital, 86021 Poitiers, France;
8 Department of Radiology, Poitiers University Hospital, 86021 Poitiers, France;
9 Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, QC G1V 0A6, Canada;
10 CEA Cadarache, Département de Support Technique et Gestion, Service des Technologies de l’Information et de la Communication, 13108 Saint-Paul-Lez-Durance, France;
11 PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France;