title: High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study.
abstract: OBJECTIVE
  The objective of this prospective, open-label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high-frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs.
  
  
  METHODS
  Eighty-three patients, with significant back pain, were recruited for a trial of high-frequency stimulation through two percutaneous eight-contact epidural leads. Patients' pain ratings, disability, sleep disturbances, and satisfaction, as well as complication rates, were assessed for up to six months.
  
  
  RESULTS
  After a trial period, 88% (72 out of 82) of patients reported a significant improvement in visual analog scale (VAS) scores and underwent permanent implantation of the high-frequency SCS system. Mean back pain VAS of 8.4 was reduced to 2.7 at six months (p< 0.001). Mean leg pain VAS of 5.4 was reduced to 1.4 at six months (p< 0.001). Seventy-four percent of patients had greater than 50% back pain relief at six months. There were significant improvements in Oswestry disability score and sleep, and reductions in pain medication use. Adverse events observed were those seen with conventional SCS therapy--lead migration, wound infection, and pain around implant site.
  
  
  CONCLUSIONS
  In a cohort of patients with difficult-to-treat chronic back pain, high-frequency SCS provided significant and sustained low back pain and leg pain relief to more than 70% of treated subjects. Notably, this was achieved without paresthesia. Patients also experienced significant improvement in disability and sleep. Overall, the results confirm a favorable safety and efficacy profile of the high-frequency SCS system.
authors.affiliation: Department of Anesthesia and Pain Management, AZ Nikolaas, St Niklaas, Belgium. vanbuyten@skynet.be
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Van Buyten
authors.forename: Adnan
authors.initials: A
authors.lastname: Al-Kaisy
authors.forename: Iris
authors.initials: I
authors.lastname: Smet
authors.forename: Stefano
authors.initials: S
authors.lastname: Palmisani
authors.forename: Thomas
authors.initials: T
authors.lastname: Smith
mesh_terms: D001416:Back Pain / Q000628:therapy*; D059350:Chronic Pain / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D013116:Spinal Cord / Q000502:physiology*; D062187:Spinal Cord Stimulation / Q000379:methods*; D016896:Treatment Outcome