title: A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome.
abstract: OBJECTIVE
  Spinal cord stimulation (SCS) for the treatment of chronic pain is a well-established therapy. However, the requirement that paresthesia be continually felt by the patient has important downsides. This study evaluated the effectiveness of a new paresthesia-free SCS paradigm, called burst stimulation, for the treatment of failed back surgery syndrome (FBSS) with a prospective, randomized, double-blind, placebo-controlled design.
  
  
  METHODS
  Twenty patients with FBSS and a preexisting SCS system each received three treatment allocations in random order for a period of one week: 500-Hz tonic stimulation, burst stimulation, and placebo stimulation. The primary outcome measure was pain intensity measured on a numerical rating scale (NRS). Secondary outcome measures were pain quality measured using the Short-Form McGill Pain Questionnaire (SFMPQ) and safety. Additional data were collected relating to pain-related disability measured using the Oswestry Disability Index (ODI).
  
  
  RESULTS
  The lowest mean NRS and SFMPQ scores were observed under burst stimulation. For the burst stimulation treatment group, mean NRS and SFMPQ scores were significantly decreased compared with the other treatment groups. Mean NRS and SFMPQ scores were not significantly different between 500-Hz tonic stimulation and placebo stimulation. Although the lowest mean ODI score was observed under burst stimulation, no significant differences were found between the ODI categories. No adverse events occurred, and burst stimulation was significantly preferred by 16 patients (80%).
  
  
  CONCLUSIONS
  Overall, burst stimulation resulted in significantly better pain relief and improved pain quality in the short term compared with 500-Hz tonic stimulation and placebo stimulation and was preferred by the majority of patients.
authors.affiliation: Department of Functional Neurosurgery and Stereotaxy, Neurosurgical Clinic, Heinrich Heine University, Düsseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Schu
authors.forename: Philipp J
authors.initials: PJ
authors.lastname: Slotty
authors.forename: Gregor
authors.initials: G
authors.lastname: Bara
authors.forename: Monika
authors.initials: M
authors.lastname: von Knop
authors.forename: Deborah
authors.initials: D
authors.lastname: Edgar
authors.forename: Jan
authors.initials: J
authors.lastname: Vesper
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001703:Biophysics; D004185:Disability Evaluation; D004311:Double-Blind Method; D055111:Failed Back Surgery Syndrome / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058748:Pain Perception; D011446:Prospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods*; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: Burst stimulation; failed back surgery syndrome; neurostimulation; spinal cord stimulation