title: Spinal cord stimulation electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes.
abstract: OBJECTIVE
  Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients.
  
  
  METHODS
  Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined "success" as at least 50% sustained relief of pain and patient satisfaction with the result of treatment.
  
  
  RESULTS
  At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed.
  
  
  CONCLUSIONS
  Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.
authors.affiliation: Department of Neurosurgery, School of Medicine, Johns Hopkins University, Baltimore, Maryland 21287-7881, USA.
authors.forename: Richard B
authors.initials: RB
authors.lastname: North
authors.forename: David H
authors.initials: DH
authors.lastname: Kidd
authors.forename: Loredana
authors.initials: L
authors.lastname: Petrucci
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Dorsi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004558:Electric Stimulation / Q000295:instrumentation / Q000379:methods*; D004566:Electrodes; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007796:Laminectomy / Q000379:methods; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D013118:Spinal Cord Diseases / Q000628:therapy*; D013997:Time Factors; D004561:Transcutaneous Electric Nerve Stimulation