title: Results From the Partnership for Advancement in Neuromodulation Registry: A 24-Month Follow-Up.
abstract: OBJECTIVE
  This longitudinal, clinical outcome study was a multicenter, prospective, observational, registry with a 24-month assessment of patients implanted with spinal cord stimulation (SCS) systems for the management of chronic pain of the trunk and/or limbs.
  
  
  METHODS
  On informed consent and institutional review board approval, 614 patients from 39 sites were enrolled within 30 days following permanent SCS system implantation. Medication usage, patient-reported pain relief (PRP), categorical ratings of pain relief, pain disability index scores (PDI), quality of life (QoL), and patient satisfaction were assessed at enrollment, 3-, 6-, 12-, 18-, and 24-month postimplant. Device-related adverse events (AEs) were recorded and reported.
  
  
  RESULTS
  Across all visits, statistically significant improvements were reported on all outcome measures. Mean PRP was 58.5% (± 26.4) at 3 months, 56.8% (± 29.2) at 6 months, 57.7% (± 28.9) at 12 months, 55.6% (± 29.8) at 18 months, and 56.3% (± 30.3) at 24 months. More than 65% of patients at any visit reported a PRP ≥ 50%. Mean PDI scores reduced from 46.9 points at baseline to 32.7, 31.8, 31.5, 32.1, 32.1 points at 3, 6, 12, 18, and 24 months (p ≤ 0.0001), respectively. Greater than 76% of patients at any visit were satisfied with their therapy. The majority of patients categorized pain relief as excellent or good on a 5-item scale and reported overall QoL as greatly improved or improved on a 5-item scale. An average of 88% of patients stopped, decreased, or did not change dose of narcotics/opioids. The most common AE was diminished or loss of pain relief in 11.4% of enrolled patients.
  
  
  CONCLUSIONS
  Most patients experienced substantial pain relief and a significant improvement in all outcome measures. These results further support the safety, efficacy, and sustainability of SCS in clinical practice.
authors.affiliation: Center for Pain Relief, Charleston, WV, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Deer
authors.affiliation: Greater Houston Pain Consultants, U.S. Anesthesia Partners, Houston, TX, USA.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Skaribas
authors.affiliation: Arizona Pain Specialists, Scottsdale, AZ, USA.
authors.forename: Tory
authors.initials: T
authors.lastname: McJunkin
authors.affiliation: Bluegrass Pain Consultants, Louisville, KY, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Nelson
authors.affiliation: PainCare Network, Perth Western, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Salmon
authors.affiliation: Spine Team Texas, Southlake, TX, USA.
authors.forename: Amit
authors.initials: A
authors.lastname: Darnule
authors.affiliation: The Spine Diagnostic and Pain Treatment Center, Baton Rouge, LA, USA.
authors.forename: John
authors.initials: J
authors.lastname: Braswell
authors.affiliation: Hunter Pain Clinic, Newcastle, NSW, Australia.
authors.forename: Marc
authors.initials: M
authors.lastname: Russo
authors.affiliation: Fundacion Cardiovascular de Colombia, Bucaramanga Santander, Colombia.
authors.forename: Omar
authors.initials: O
authors.lastname: Fernando Gomezese
mesh_terms: D059350:Chronic Pain / Q000628:therapy*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D020127:Recovery of Function; D012042:Registries; D062187:Spinal Cord Stimulation; D016896:Treatment Outcome
keywords: Chronic pain; clinical trial; registry; spinal cord stimulation