title: A prospective study evaluating sleep quality in Failed Back Surgery Syndrome patients treated by multicolumn spinal cord stimulation: study design protocol and presentation of the study population.
abstract: OBJECTIVE
  One of the main consequences of chronic pain syndrome is major impairment of the quality of sleep. Chronic pain and insomnia are independently linked to significant reductions in quality of life and psychiatric morbidity. Recent studies have suggested the efficacy of spinal cord stimulation (SCS) for the treatment of the back pain component in failed back surgery syndrome (FBSS) patients using a multicolumn lead. The main aim of this pilot study is to assess the influence and potential benefits of SCS on sleep quality in refractory FBSS patients implanted with multicolumn SCS and enrolled in the French multicentre ESTIMET study.
  
  
  METHODS
  This is a single-centre, comparative, exploratory, pilot study. Sixteen FBSS patients enrolled in the ESTIMET study and implanted with multicolumn SCS will be monitored for 6months after implantation. Sleep parameters will be recorded by polysomnography, Psychomotor Vigilance Test and Osler tests, actigraphy, sleepiness scales, and sleep quality testing. Sleep will be evaluated before (at the inclusion visit) and after SCS implantation (at the 6-month visit). Secondary objectives will also assess the impact of SCS lead programming (mono vs. multicolumn SCS) and the influence of position-adaptive stimulation at night on sleep quality.
  
  
  METHODS
  The first patient of this ancillary study was enrolled on 21 May, 2012 and recruitment has now been achieved. Primary endpoint findings are expected to be available in 2015.
  
  
  CONCLUSIONS
  By providing an analysis of the quality of sleep in chronic pain patients who are candidates for implanted neurostimulation, this new approach focuses on an important aspect of quality of life often overlooked in these poly-medication patients. It could show a real clinical benefit and underestimation of these analgesic innovative expensive techniques, where medico-economic analysis, would or would not promote access.
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France; Department of neurosurgery, spine-neurostimulation unit, Poitiers university hospital, Poitiers, France. Electronic address: olivier.monlezun@chu-poitiers.fr.
authors.forename: O
authors.initials: O
authors.lastname: Monlezun
authors.affiliation: Sleep center, Poitiers university hospital, Poitiers, France.
authors.forename: K
authors.initials: K
authors.lastname: Lode-Kolz
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France; Department of neurosurgery, spine-neurostimulation unit, Poitiers university hospital, Poitiers, France.
authors.forename: M
authors.initials: M
authors.lastname: Roulaud
authors.affiliation: Sleep center, Poitiers university hospital, Poitiers, France.
authors.forename: J
authors.initials: J
authors.lastname: Paquereau
authors.affiliation: Faculty of medicine and pharmacy, Poitiers university hospital, Poitiers, France.
authors.forename: P
authors.initials: P
authors.lastname: Ingrand
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Veyrieras
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Brandet
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France.
authors.forename: F
authors.initials: F
authors.lastname: Guetarni
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France.
authors.forename: A
authors.initials: A
authors.lastname: Prévost
authors.affiliation: Department of neurosurgery, spine-neurostimulation unit, Poitiers university hospital, Poitiers, France.
authors.forename: B
authors.initials: B
authors.lastname: Bataille
authors.affiliation: Service de neurochirurgie, unité rachis et neurostimulation, N3Lab (Neuromodulation & Neural Networks), CHU de Poitiers, Poitiers University Hospital, 2, rue de la Milétrie, 86021 Poitiers cedex, France; Department of neurosurgery, spine-neurostimulation unit, Poitiers university hospital, Poitiers, France.
authors.forename: P
authors.initials: P
authors.lastname: Rigoard
mesh_terms: D000328:Adult; D000368:Aged; D001143:Arousal; D004567:Electrodes, Implanted; D023381:Endpoint Determination; D055111:Failed Back Surgery Syndrome / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D017286:Polysomnography; D011446:Prospective Studies; D011597:Psychomotor Performance; D012107:Research Design; D012890:Sleep; D062187:Spinal Cord Stimulation / Q000379:methods*; D055815:Young Adult
keywords: Actigraphie; Actigraphy; Chronic pain; Douleur chronique; Failed back surgery syndrome; Polysomnographie; Polysomnography; Qualité du sommeil; Sleep quality; Spinal cord stimulation; Stimulation médullaire épidurale