Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study)

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Udgivet i:Medicina vol. 58, no. 1 (2022), p. 7
Hovedforfatter: Rigoard, Philippe
Andre forfattere: Roulaud, Manuel, Goudman, Lisa, Adjali, Nihel, Ounajim, Amine, Voirin, Jimmy, Perruchoud, Christophe, Bouche, Bénédicte, Page, Philippe, Guillevin, Rémy, Naudin, Mathieu, Simoneau, Martin, Lorgeoux, Bertille, Baron, Sandrine, Nivole, Kevin, Many, Mathilde, Maitre, Iona, Rigoard, Raphaël, Romain, David, Moens, Maarten, Billot, Maxime
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MDPI AG
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024 7 |a 10.3390/medicina58010007  |2 doi 
035 |a 2621327765 
045 2 |b d20220101  |b d20221231 
100 1 |a Rigoard, Philippe  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.); Department of Spine Surgery & Neuromodulation, Poitiers University Hospital, 86021 Poitiers, France; <email>Philippe.PAGE@chu-poitiers.fr</email>; Pprime Institute UPR 3346, CNRS, ISAE-ENSMA, University of Poitiers, 86360 Chasseneuil-du-Poitou, France 
245 1 |a Comparison of Spinal Cord Stimulation vs. Dorsal Root Ganglion Stimulation vs. Association of Both in Patients with Refractory Chronic Back and/or Lower Limb Neuropathic Pain: An International, Prospective, Randomized, Double-Blinded, Crossover Trial (BOOST-DRG Study) 
260 |b MDPI AG  |c 2022 
513 |a Evidence Based Healthcare Journal Article 
520 3 |a 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. 
651 4 |a France 
653 |a Clinical trials 
653 |a Generators 
653 |a Quality of life 
653 |a Peripheral neuropathy 
653 |a Back pain 
653 |a Hypotheses 
653 |a Spinal cord 
653 |a Energy consumption 
653 |a Foot diseases 
653 |a Patient satisfaction 
700 1 |a Roulaud, Manuel  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Goudman, Lisa  |u Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium; <email>lisa.goudman@gmail.com</email> (L.G.); <email>mtmoens@gmail.com</email> (M.M.); STUMULUS Research Group, Vrije Universiteit Brussel, 1090 Brussels, Belgium 
700 1 |a Adjali, Nihel  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Ounajim, Amine  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Voirin, Jimmy  |u Department of Neurosurgery, Hopitaux Civils de Colmar, 68000 Colmar, France; <email>jimmy.voirin@ch-colmar.fr</email> 
700 1 |a Perruchoud, Christophe  |u Service of Anesthesiology and Pain Centre, University Hospital of Lausanne (CHUV), 1011 Lausanne, Switzerland; <email>christophe.perruchoud@chuv.ch</email> 
700 1 |a Bouche, Bénédicte  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.); Department of Spine Surgery & Neuromodulation, Poitiers University Hospital, 86021 Poitiers, France; <email>Philippe.PAGE@chu-poitiers.fr</email> 
700 1 |a Page, Philippe  |u Department of Spine Surgery & Neuromodulation, Poitiers University Hospital, 86021 Poitiers, France; <email>Philippe.PAGE@chu-poitiers.fr</email> 
700 1 |a Guillevin, Rémy  |u Department of Radiology, Poitiers University Hospital, 86021 Poitiers, France; <email>remy.guillevin@chu-poitiers.fr</email> (R.G.); <email>mathieu.naudin@chu-poitiers.fr</email> (M.N.); UMR CNRS 7348, DACTIM-MIS/LMA Laboratory, University of Poitiers, 86000 Poitiers, France 
700 1 |a Naudin, Mathieu  |u Department of Radiology, Poitiers University Hospital, 86021 Poitiers, France; <email>remy.guillevin@chu-poitiers.fr</email> (R.G.); <email>mathieu.naudin@chu-poitiers.fr</email> (M.N.); UMR CNRS 7348, DACTIM-MIS/LMA Laboratory, University of Poitiers, 86000 Poitiers, France 
700 1 |a Simoneau, Martin  |u Department of Kinesiology, Faculty of Medicine, Laval University, Quebec, QC G1V 0A6, Canada; <email>martin.simoneau@kin.ulaval.ca</email>; Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale (CIRRIS), Quebec, QC G1M 2S8, Canada 
700 1 |a Lorgeoux, Bertille  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Baron, Sandrine  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Nivole, Kevin  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Many, Mathilde  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Maitre, Iona  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
700 1 |a Rigoard, Raphaël  |u CEA Cadarache, Département de Support Technique et Gestion, Service des Technologies de l’Information et de la Communication, 13108 Saint-Paul-Lez-Durance, France; <email>cydran@gmail.com</email> 
700 1 |a Romain, David  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.); Department of Physical and Rehabilitation Medicine, Poitiers University Hospital, University of Poitiers, 86021 Poitiers, France 
700 1 |a Moens, Maarten  |u Department of Neurosurgery, Universitair Ziekenhuis Brussel, 1090 Brussels, Belgium; <email>lisa.goudman@gmail.com</email> (L.G.); <email>mtmoens@gmail.com</email> (M.M.); STUMULUS Research Group, Vrije Universiteit Brussel, 1090 Brussels, Belgium 
700 1 |a Billot, Maxime  |u PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, 86021 Poitiers, France; <email>Manuel.ROULAUD@chu-poitiers.fr</email> (M.R.); <email>Nihel.adjali@chu-poitiers.fr</email> (N.A.); <email>Amine.OUNAJIM@chu-poitiers.fr</email> (A.O.); <email>dr.bouche@gmail.com</email> (B.B.); <email>Bertille.LORGEOUX@chu-poitiers.fr</email> (B.L.); <email>sandrine.baron@chu-poitiers.fr</email> (S.B.); <email>Kevin.NIVOLE@chu-poitiers.fr</email> (K.N.); <email>mathilde.many@chu-poitiers.fr</email> (M.M.); <email>iona.maitre@etu.univ-poitiers.fr</email> (I.M.); <email>romain-david@hotmail.fr</email> (R.D.); <email>Maxime.BILLOT@chu-poitiers.fr</email> (M.B.) 
773 0 |t Medicina  |g vol. 58, no. 1 (2022), p. 7 
786 0 |d ProQuest  |t Health & Medical Collection 
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