title: Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study.
abstract: OBJECTIVE
  The aim of this study was to investigate the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable pain of the low back and legs.
  
  
  METHODS
  Prospective, multicenter, observational study.
  
  
  METHODS
  Patients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months.
  
  
  RESULTS
  After a trial period, 88% (72 of 82) of patients reported a significant improvement in pain scores and underwent the permanent implantation of the system. Ninety percent (65 of 72) of patients attended a 24-month follow-up visit. Mean back pain was reduced from 8.4 ± 0.1 at baseline to 3.3 ± 0.3 at 24 months (P < 0.001), and mean leg pain from 5.4 ± 0.4 to 2.3 ± 0.3 (P < 0.001). Concomitantly to the pain relief, there were significant decreases in opioid use, Oswestry Disability Index score, and sleep disturbances. Patients' satisfaction and recommendation ratings were high. Adverse Events were similar in type and frequency to those observed with traditional SCS systems.
  
  
  CONCLUSIONS
  In patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements, opioid use reduction, and high patient satisfaction. These results support the long-term safety and sustained efficacy of HF10 SCS.
authors.affiliation: The Pain Management and Neuromodulation Centre, Guy's and St. Thomas' Hospital, London, UK.
authors.forename: Adnan
authors.initials: A
authors.lastname: Al-Kaisy
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Van Buyten
authors.forename: Iris
authors.initials: I
authors.lastname: Smet
authors.forename: Stefano
authors.initials: S
authors.lastname: Palmisani
authors.forename: David
authors.initials: D
authors.lastname: Pang
authors.forename: Thomas
authors.initials: T
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D059350:Chronic Pain / Q000628:therapy*; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods; D016896:Treatment Outcome
keywords: Chronic Low Back Pain; Failed Back Surgery Syndrome; High-Frequency Stimulation; Spinal Cord Stimulation