title: Subcutaneous Stimulation as ADD-ON Therapy to Spinal Cord Stimulation Is Effective in Treating Low Back Pain in Patients With Failed Back Surgery Syndrome: A Multicenter Randomized Controlled Trial.
abstract: OBJECTIVE
  Suppression of back pain with traditional spinal cord stimulation (SCS) in failed back surgery syndrome patients is often insufficient. The objective of this study was to investigate the efficacy of subcutaneous stimulation (SubQ) as ADD-ON therapy to SCS in treating back pain in failed back surgery syndrome patients.
  
  
  METHODS
  Patients with a minimal pain score of 50 on a 100 mm visual analog scale for both leg and back pain were eligible. If pain reduction after trial SCS was ≥50% for the leg but <50% for the back, patients received additional SubQ leads and were randomized in a 1:1 ratio in a study arm with subcutaneous leads switched on (SubQ ADD-ON) and an arm with subcutaneous leads switched off (Control). The primary outcome was the percentage of the patients, at three months since implantation, with ≥50% reduction of back pain.
  
  
  RESULTS
  A total of 97 patients were treated with SCS for leg and back pain. Of these, 52 patients were randomized and allocated to the Control group (n = 24) or to the SubQ ADD-ON group (n = 28). The percentage of patients with ≥50% reduction of back pain was significantly higher in the SubQ ADD-ON group (42.9%) compared to the Control group (4.2%). Mean visual analog scale for back pain, at three months, was a statistically significant 28.1 mm lower in the SubQ ADD-ON group compared to the Control group.
  
  
  CONCLUSIONS
  Subcutaneous stimulation as an ADD-ON therapy to SCS is effective in treating back pain in failed back surgery syndrome patients where SCS is only effective for pain in the leg.
authors.affiliation: Department of Anesthesiology and Pain Medicine Albert Schweitzer ziekenhuis Sliedrecht, The Netherlands.
authors.forename: Eric-Jan J A A
authors.initials: EJ
authors.lastname: van Gorp
authors.affiliation: Department of Neurosurgery, Atrium ziekenhuis Heerlen, The Netherlands.
authors.forename: Onno P M
authors.initials: OP
authors.lastname: Teernstra
authors.affiliation: Department of Anesthesiology and Pain Medicine Albert Schweitzer ziekenhuis Sliedrecht, The Netherlands.
authors.forename: Ismail
authors.initials: I
authors.lastname: Gültuna
authors.affiliation: Department of Anesthesiology and Pain Medicine Albert Schweitzer ziekenhuis Sliedrecht, The Netherlands.
authors.forename: Tanja
authors.initials: T
authors.lastname: Hamm-Faber
authors.affiliation: Department of Anesthesiology and Pain Medicine Rijnland Ziekenhuis Leiderdorp, The Netherlands.
authors.forename: Katja
authors.initials: K
authors.lastname: Bürger
authors.affiliation: Department of Anesthesiology and Pain Medicine Diakonessenhuis Zeist/Utrecht, The Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: Schapendonk
authors.affiliation: Department of Anesthesiology and Pain Medicine Rijnstate Ziekenhuis Arnhem, The Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: Willem Kallewaard
authors.affiliation: Department of Neurosurgery, University Medical Center Maastricht, Maastricht, The Netherlands, retired.
authors.forename: Geert
authors.initials: G
authors.lastname: Spincemaille
authors.affiliation: Department of Anesthesiology and Pain Medicine Sint Maartenskliniek Nijmegen, The Netherlands.
authors.forename: Leon H
authors.initials: LH
authors.lastname: Vonhögen
authors.affiliation: Radboud Institute for Health Sciences, Department for Health Evidence, Radboud University Medical Centre, The Netherlands.
authors.forename: Jan C M
authors.initials: JC
authors.lastname: Hendriks
authors.affiliation: Department of Anesthesiology, Pain- and Palliative Medicine Radboud University Medical Centre, The Netherlands.
authors.forename: Kris C P
authors.initials: KC
authors.lastname: Vissers
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000379:methods*; D055111:Failed Back Surgery Syndrome / Q000628:therapy*; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D062187:Spinal Cord Stimulation / Q000379:methods*; D040521:Subcutaneous Tissue
keywords: PNFS; chronic low back pain; failed back surgery syndrome; spinal cord stimulation; subcutaneous stimulation