title: Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER.
abstract: The EMP3OWER™ study evaluated spinal cord stimulation (SCS) safety and efficacy and the associated changes in psychosocial and functional outcomes.
  
  
  
  Upon informed consent and IRB approval, 620 eligible subjects were enrolled prior to SCS trial evaluation and were assessed at baseline, 3, 6 and 12 months post-implant. Patient-reported pain relief (PRP), numerical rating scale (NRS), satisfaction, quality of life (QOL), and pain disability index (PDI) were assessed at all follow-up visits while the pain catastrophizing scale (PCS), short form-36 (SF-36), short form-McGill pain questionnaire version 2 (SF-MPQ-2), and the state-trait anxiety inventory (STAI) were assessed at the 6- and 12-month follow-up visits. Device and/or procedure-related adverse events were also recorded and reported. Subjects reporting a PRP ≥ 50% were considered responders. Repeated measures analysis of variance (RMANOVA) examined the changes across time for all continuous measures.
  
  
  
  A total of 401 (71%) subjects received a permanent implant. Mean (±SD) patient-reported pain relief was 59.3% (±26.2), 59.2% (±28.9), and 58.2% (±32.0) at 3, 6, and 12 months, respectively. A majority of enrolled subjects were responders at 3 (75.5%), 6 (74.7%), and 12 months (69.7%). RMANOVA revealed a statistically significant change for NRS, PCS, PDI, SF-36, SF-MPQ-2, and STAI scores. At 3 months, the majority of subjects (85.7%) were either very satisfied or satisfied with their device, with similar results at 6 and 12 months. At 3 months, the majority of subjects (73.3%) reported greatly improved or improved QOL with similar results at 6 and 12 months.
  
  
  
  Spinal cord stimulation provided pain relief and significant improvement of patient psychological and functional outcome measures.
authors.affiliation: *SC Pain and Spine Specialists LLC, Murrells Inlet, South Carolina jrmdjr@yahoo.com.
authors.forename: Jason
authors.initials: J
authors.lastname: Rosenberg
authors.affiliation: Bronson Neuroscience Center, Kalamazoo, Mississippi.
authors.forename: Alain
authors.initials: A
authors.lastname: Fabi
authors.affiliation: Advocate Illinois Masonic Medical Center, Chicago, Illinois.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Candido
authors.affiliation: Advocate Illinois Masonic Medical Center, Chicago, Illinois.
authors.forename: Nick
authors.initials: N
authors.lastname: Knezevic
authors.affiliation: Central Florida Pain Relief Centers, Orlando, Florida.
authors.forename: Michael
authors.initials: M
authors.lastname: Creamer
authors.affiliation: Rhode Island Hospital, Providence, Rhode Island.
authors.forename: Alexios
authors.initials: A
authors.lastname: Carayannopoulos
authors.affiliation: PARS Neurosurgical Associates, Parkersburg, West Virginia.
authors.forename: Abdi
authors.initials: A
authors.lastname: Ghodsi
authors.affiliation: Bluegrass Pain Consultants, Louisville, Kentucky.
authors.forename: Christopher
authors.initials: C
authors.lastname: Nelson
authors.affiliation: Tier Orthopedic Associates, Johnson City, New York, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Bennett
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000628:therapy*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D017060:Patient Satisfaction; D011788:Quality of Life; D062187:Spinal Cord Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
keywords: Chronic Pain; Functional Outcomes; Psychosocial Outcomes; Spinal Cord Stimulation