title: Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).
abstract: BACKGROUND
  Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain.
  
  
  METHODS
  FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption.
  
  
  METHODS
  Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112/115 patients have been enrolled. Preliminary results are expected to be published in 2015.
  
  
  BACKGROUND
  Clinical trial registration information-URL: www.clinicaltrials.gov. Unique identifier NCT01628237.
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France. Electronic address: manuel.roulaud@chu-poitiers.fr.
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authors.affiliation: Clinical Research Unit in Economics, Hôtel Dieu, 75004 Paris, France.
authors.forename: I
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authors.lastname: Durand-Zaleski
authors.affiliation: Faculty of medicine and pharmacy, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: P
authors.initials: P
authors.lastname: Ingrand
authors.affiliation: Pain Evaluation and Treatment Centre, Lariboisière Hospital, 75010 Paris, France.
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authors.lastname: Serrie
authors.affiliation: Pain Evaluation and Treatment Centre, Poitiers University Hospital, 86000 Poitiers, France.
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authors.lastname: Diallo
authors.affiliation: Department of Neurosurgery, Reims University Hospital, 51092 Reims, France.
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authors.affiliation: Pain Evaluation and Treatment Centre, Brest University Hospital, 29200 Brest, France.
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authors.affiliation: Department of Neurosurgery, Colmar Hospital, 68024 Colmar, France.
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authors.affiliation: Department of Neurosurgery, Nantes University Hospital, 44093 Nantes, France.
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authors.lastname: Raoul
authors.affiliation: Department of Neurosurgery, Sainte-Anne Hospital, AP-HP, 75014 Paris, France.
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authors.lastname: Page
authors.affiliation: Department of Neurosurgery, Nice University Hospital, 06003 Nice, France.
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authors.lastname: Fontaine
authors.affiliation: Department of Neurosurgery, Nice University Hospital, 06003 Nice, France.
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authors.lastname: Lantéri-Minet
authors.affiliation: Department of Neurosurgery, Lille University Hospital, 59037 Lille, France.
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authors.lastname: Blond
authors.affiliation: Department of Neurosurgery, Lille University Hospital, 59037 Lille, France.
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authors.affiliation: Department of Neurosurgery, Bordeaux University Hospital, 33076 Bordeaux, France.
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authors.affiliation: Department of Neurosurgery, Bordeaux University Hospital, 33076 Bordeaux, France.
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authors.lastname: Cadenne
authors.affiliation: Department of Neurosurgery, Limoges University Hospital, 87042 Limoges, France.
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authors.lastname: Caire
authors.affiliation: Department of Neurosurgery, Limoges University Hospital, 87042 Limoges, France.
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authors.lastname: Ranoux
authors.affiliation: Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.
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authors.lastname: Mertens
authors.affiliation: Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.
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authors.lastname: Naous
authors.affiliation: Department of Neurosurgery, Lyon University Hospital, 69677 Lyon, France.
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authors.lastname: Simon
authors.affiliation: Department of Neurosurgery, Caen University Hospital, 14000 Caen, France.
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authors.lastname: Emery
authors.affiliation: Department of Neurosurgery, Caen University Hospital, 14000 Caen, France.
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authors.lastname: Gadan
authors.affiliation: Department of Neurosurgery, AP-HM, Timone Hospital, 13385 Marseille, France.
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authors.lastname: Regis
authors.affiliation: Department of Neurosurgery, Toulouse University Hospital, 31000 Toulouse, France.
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authors.affiliation: Internal Medicine/Infectious and Tropical Diseases Department, Poitiers University Hospital, 86000 Poitiers, France.
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authors.lastname: Béraud
authors.affiliation: Department of Rheumatology, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: F
authors.initials: F
authors.lastname: Debiais
authors.affiliation: Department of Rheumatology, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: G
authors.initials: G
authors.lastname: Durand
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: F
authors.initials: F
authors.lastname: Guetarni Ging
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: A
authors.initials: A
authors.lastname: Prévost
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: C
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authors.lastname: Brandet
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: O
authors.initials: O
authors.lastname: Monlezun
authors.affiliation: Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: A
authors.initials: A
authors.lastname: Delmotte
authors.affiliation: Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: S
authors.initials: S
authors.lastname: d'Houtaud
authors.affiliation: Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.
authors.forename: B
authors.initials: B
authors.lastname: Bataille
authors.affiliation: N(3)lab (Neuromodulation and Neural Networks), Inserm CIC 802, Poitiers University Hospital, 86000 Poitiers, France; Department of Neurosurgery, Spine-Neurostimulation Unit, Poitiers University Hospital, 86000 Poitiers, France.
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mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003362:Cost-Benefit Analysis; D004567:Electrodes, Implanted; D023381:Endpoint Determination; D055111:Failed Back Surgery Syndrome / Q000150:complications* / Q000191:economics / Q000628:therapy*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000191:economics / Q000209:etiology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000379:methods; D010147:Pain Measurement; D011446:Prospective Studies; D012107:Research Design; D062187:Spinal Cord Stimulation / Q000191:economics* / Q000379:methods*; D055815:Young Adult
keywords: Douleurs lombaires; Douleurs neuropathiques; Failed back surgery syndrome; Health economics evaluation; Lombo-radiculalgies postopératoires; Low back pain; Neuropathic pain; Randomized controlled trial; Spinal cord stimulation; Stimulation médullaire épidurale; Étude randomisée contrôlée; Évaluation médico-économique