title: Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study.
abstract: To evaluate the effectiveness and safety of percutaneous octapolar (8-contact) leads in spinal cord stimulation (SCS) treatment of failed back surgery syndrome (FBSS) patients who have not reached their therapy goals with other treatment interventions.
  
  
  
  Our prospective, multicenter, open-label, nonrandomized study included 93 patients ≥ 18 years of age suffering from chronic (≥ 6 months), intractable pain predominantly in the legs. Patients implanted with octapolar lead(s) and a neurostimulator after a successful test trial were followed for 12 months. Patients provided self-reported data on change in visual analog scale (VAS) score for leg pain (primary outcome) and low back pain, quality of life (EuroQol 5 dimensions [EQ-5D] index), sleep, medication use, and paresthesia coverage (secondary outcomes). Adverse events and preferred stimulation settings were documented.
  
  
  
  Eighty-one (87%) patients had a successful SCS trial. Patients reported significantly improved leg pain relief; average VAS score was 72 ± 17 prior to SCS treatment and 32 ± 24 at 12 months (P < 0.001). Significant decrease in back pain (P < 0.001), improvement in quality of life (P < 0.001), and improvement in sleep (P < 0.05) was observed. Sixty-three percent and 40% of patients were responders (≥ 50% pain reduction) on leg and back pain, respectively, after 12 months. A decrease in medication use was seen for antidepressants and anticonvulsants. Eighty-eight percent of the patients managed with 1 or 2 programs for optimal effect and paresthesia coverage. Twenty-five SCS-related adverse events were registered in 22 patients (24%). Surgical revision due to lead displacement or dysfunction was needed in 6 (6%) of the patients.
  
  
  
  Use of percutaneous octapolar SCS leads gives significant long-term pain relief and improvement in quality of life and sleep in FBSS patients. The outcomes are better than reported on 4-contact leads and indicate that the progress in SCS technology that has taken place during the past decade correlates with therapy improvements.
authors.affiliation: Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors.forename: Kliment
authors.initials: K
authors.lastname: Gatzinsky
authors.affiliation: Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.
authors.forename: Roald
authors.initials: R
authors.lastname: Baardsen
authors.affiliation: Neuromodulation External Research & Innovation, Medtronic Europe, Eindhoven, the Netherlands.
authors.forename: Hendrik P
authors.initials: HP
authors.lastname: Buschman
mesh_terms: D000328:Adult; D000368:Aged; D055111:Failed Back Surgery Syndrome / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D038622:Internationality; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000295:instrumentation* / Q000592:standards*; D010147:Pain Measurement / Q000295:instrumentation / Q000592:standards; D011446:Prospective Studies; D011788:Quality of Life; D062187:Spinal Cord Stimulation / Q000295:instrumentation* / Q000592:standards*; D016896:Treatment Outcome
keywords: chronic pain; failed back surgery syndrome; neuromodulation technology; pain relief; percutaneous leads; spinal cord stimulation