title: Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial.
abstract: OBJECTIVE
  Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment is often partially effective or accompanied by unacceptable side effects, and new treatments are urgently needed. Small observational studies suggested that spinal cord stimulation (SCS) may have positive effects.
  
  
  METHODS
  We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment (BMT) (SCS group) and 14 to BMT only (BMT group). The SCS system was implanted only if trial stimulation was successful. Treatment success was defined as ≥50% pain relief during daytime or nighttime or "(very) much improved" for pain and sleep on the patient global impression of change (PGIC) scale at 6 months.
  
  
  RESULTS
  Trial stimulation was successful in 77% of the SCS patients. Treatment success was observed in 59% of the SCS and in 7% of the BMT patients (P < 0.01). Pain relief during daytime and during nighttime was reported by 41 and 36% in the SCS group and 0 and 7% in the BMT group, respectively (P < 0.05). Pain and sleep were "(very) much improved" in 55 and 36% in the SCS group, whereas no changes were seen in the BMT group, respectively (P < 0.001 and P < 0.05). One SCS patient died because of a subdural hematoma.
  
  
  CONCLUSIONS
  Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands rachel.slangen@gmail.com maarten.van.kleef@mumc.nl.
authors.forename: Rachel
authors.initials: R
authors.lastname: Slangen
authors.affiliation: Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Nicolaas C
authors.initials: NC
authors.lastname: Schaper
authors.affiliation: Department of Neurology, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Catharina G
authors.initials: CG
authors.lastname: Faber
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Elbert A
authors.initials: EA
authors.lastname: Joosten
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands CAPHRI School of Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands.
authors.forename: Carmen D
authors.initials: CD
authors.lastname: Dirksen
authors.affiliation: Department of Anesthesiology, Pain, and Palliative Care, Radboud University Medical Centre, Nijmegen, the Netherlands.
authors.forename: Robert T
authors.initials: RT
authors.lastname: van Dongen
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Alfons G
authors.initials: AG
authors.lastname: Kessels
authors.affiliation: Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands Department of Anesthesiology, Free University of Amsterdam, Amsterdam, the Netherlands rachel.slangen@gmail.com maarten.van.kleef@mumc.nl.
authors.forename: Maarten
authors.initials: M
authors.lastname: van Kleef
mesh_terms: D000328:Adult; D000368:Aged; D003929:Diabetic Neuropathies / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006801:Humans; D035002:Lower Extremity; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D011446:Prospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods*; D016896:Treatment Outcome