Philippe Rigoard1,2,3, Maxime Billot1, Pierre Ingrand4, Isabelle Durand-Zaleski5, Manuel Roulaud1, Philippe Peruzzi6, Phong Dam Hieu7, Jimmy Voirin8, Sylvie Raoul9, Philippe Page2, Marie-Christine Djian10, Denys Fontaine11,12, Michel Lantéri-Minet12,13,14, Serge Blond15, Nadia Buisset15, Emmanuel Cuny16, Myriam Cadenne17, François Caire18, Danièle Ranoux19, Patrick Mertens20, Hussein Naous20, Emile Simon20, Evelyne Emery21, Guillaume Béraud22, Françoise Debiais23, Géraldine Durand23, Alain Serrie24, Bakari Diallo25, Julie Bulsei5, Amine Ounajim1, Kevin Nivole1, Sophie Duranton26, Nicolas Naiditch1, Olivier Monlezun1, Benoit Bataille2. 1. PRISMATICS Lab (Predictive Research In Spine/neurostimulation Management and Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France. 2. Department of Neurosurgery, Spine & Neurostimulation Unit, Poitiers University Hospital, Poitiers, France. 3. UPR 3346, CNRS, P' Institute, Futuroscope, Faculty of Sciences, Poitiers, France. 4. Faculty of Medicine and Pharmacy, Poitiers University Hospital, Poitiers, France. 5. Clinical Research Unit in Economics, Hôtel Dieu, Paris, France. 6. Department of Neurosurgery, Reims University Hospital, Reims, France. 7. Department of Neurosurgery, Brest University Hospital, Brest, France. 8. Department of Neurosurgery, Colmar Hospital, Colmar, France. 9. Department of Neurosurgery, Nantes University Hospital, Nantes, France. 10. Pain Evaluation and Treatment Centre, Foch Hospital, Suresnes, France. 11. Centre Hospitalier Universitaire de Nice, Department of Neurosurgery, Université Côte d'Azur, Nice, France. 12. FHU InovPain, Côte Azur University, Nice, France. 13. Pain Evaluation and Treatment Centre, Nice University Hospital, Nice, France. 14. INSERM U1107, Neuro-Dol, Trigeminal Pain and Migraine, Auvergne University, Clermont-Ferrand, France. 15. Department of Neurosurgery, Lille University Hospital, Lille, France. 16. Department of Neurosurgery, Bordeaux University Hospital, Bordeaux, France. 17. Pain Evaluation and Treatment Centre, Bordeaux University Hospital, Bordeaux, France. 18. Department of Neurosurgery, Limoges University Hospital, Limoges, France. 19. Pain Evaluation and Treatment Centre, Limoges University Hospital, Limoges, France. 20. Department of Neurosurgery, Lyon University Hospital, Lyon, France. 21. Department of Neurosurgery, Caen University Hospital, Caen, France. 22. Internal Medicine/Infectious and Tropical Diseases Department, Poitiers University Hospital, Poitiers, France. 23. Department of Rheumatology, Poitiers University Hospital, Poitiers, France. 24. Pain Evaluation and Treatment Centre, Lariboisière Hospital, Paris, France. 25. Pain Evaluation and Treatment Centre, Poitiers University Hospital, Poitiers, France. 26. Vigilance Department, Clinical Research Direction, Poitiers University Hospital, Poitiers, France.
Abstract
BACKGROUND: Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). OBJECTIVE: To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. MATERIALS AND METHODS: Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. RESULTS: At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). CONCLUSION: The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.
BACKGROUND: Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). OBJECTIVE: To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. MATERIALS AND METHODS: Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. RESULTS: At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). CONCLUSION: The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.
Authors: Lisa Goudman; Philippe Rigoard; Maxime Billot; Rui V Duarte; Sam Eldabe; Maarten Moens Journal: J Pain Res Date: 2022-04-20 Impact factor: 2.832
Authors: Philippe Rigoard; Amine Ounajim; Lisa Goudman; Chantal Wood; Manuel Roulaud; Philippe Page; Bertille Lorgeoux; Sandrine Baron; Kevin Nivole; Mathilde Many; Emmanuel Cuny; Jimmy Voirin; Denys Fontaine; Sylvie Raoul; Patrick Mertens; Philippe Peruzzi; François Caire; Nadia Buisset; Romain David; Maarten Moens; Maxime Billot Journal: J Clin Med Date: 2022-09-22 Impact factor: 4.964