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) - Archive ouverte HAL Access content directly
Journal Articles Neuromodulation Year : 2021

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)

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Philippe Rigoard
  • Function : Author
Maxime Billot
Pierre Ingrand
  • Function : Author
Isabelle Durand-Zaleski
  • Function : Author
Manuel Roulaud
  • Function : Author
Philippe Peruzzi
  • Function : Author
Phong Dam Hieu
  • Function : Author
Sylvie Raoul
  • Function : Author
Philippe Page
  • Function : Author
Marie-Christine Djian
  • Function : Author
Denys Fontaine
  • Function : Author
Michel Lantéri-Minet
  • Function : Author
Serge Blond
  • Function : Author
Nadia Buisset
  • Function : Author
Emmanuel Cuny
  • Function : Author
Myriam Cadenne
  • Function : Author
François Caire
  • Function : Author
Danièle Ranoux
  • Function : Author
Patrick Mertens
  • Function : Author
Hussein Naous
  • Function : Author
Emile Simon
  • Function : Author
Evelyne Emery
  • Function : Author
Guillaume Béraud
Françoise Debiais
  • Function : Author
Géraldine Durand
  • Function : Author
  • PersonId : 769669
  • IdRef : 092556523
Alain Serrie
  • Function : Author
Bakari Diallo
  • Function : Author
Julie Bulsei
  • Function : Author
Amine Ounajim
  • Function : Author
Kevin Nivole
  • Function : Author
Sophie Duranton
  • Function : Author
Nicolas Naiditch
  • Function : Author
  • PersonId : 1102961
Olivier Monlezun
  • Function : Author
Benoit Bataille
  • Function : Author

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.
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Dates and versions

hal-03268088 , version 1 (22-06-2021)

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Philippe Rigoard, Maxime Billot, Pierre Ingrand, Isabelle Durand-Zaleski, Manuel Roulaud, et al.. 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). Neuromodulation, 2021, 24 (1), pp.86-101. ⟨10.1111/ner.13251⟩. ⟨hal-03268088⟩
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