• Neuromodulation · Jan 2021

    Randomized Controlled Trial Multicenter Study

    How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double-Blind, Controlled Trial (ESTIMET Study).

    • Philippe Rigoard, Maxime Billot, Pierre Ingrand, Isabelle Durand-Zaleski, Manuel Roulaud, Philippe Peruzzi, Phong Dam Hieu, Jimmy Voirin, Sylvie Raoul, Philippe Page, Marie-Christine Djian, Denys Fontaine, Michel Lantéri-Minet, Serge Blond, Nadia Buisset, Emmanuel Cuny, Myriam Cadenne, François Caire, Danièle Ranoux, Patrick Mertens, Hussein Naous, Emile Simon, Evelyne Emery, Guillaume Béraud, Françoise Debiais, Géraldine Durand, Alain Serrie, Bakari Diallo, Julie Bulsei, Amine Ounajim, Kevin Nivole, Sophie Duranton, Nicolas Naiditch, Olivier Monlezun, and Benoit Bataille.
    • PRISMATICS Lab (Predictive Research In Spine/neurostimulation Management and Thoracic Innovation in Cardiac Surgery), Poitiers University Hospital, Poitiers, France.
    • Neuromodulation. 2021 Jan 1; 24 (1): 86-101.

    BackgroundRecent 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).ObjectiveTo compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead.Materials And MethodsTwelve 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.ResultsAt 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).ConclusionThe 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.© 2020 International Neuromodulation Society.

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