title: Use of observational mechanical gateway connector in spinal cord stimulation trials.
abstract: BACKGROUND
  Spinal cord stimulation (SCS) is an established treatment option for chronic pain. Prior to permanent implantation, temporary trials are performed to evaluate the SCS treatment. Currently there are multiple manufacturers with varying fundamental differences in delivery and resultant paresthesias. However, trials are typically limited to one manufacturer for the patient to evaluate.
  
  
  OBJECTIVE
  To evaluate the role of the Observational Mechanical Gateway (OMG) Connector for patients undergoing SCS trials.
  
  
  METHODS
  Retrospective cohort design study. Patients undergoing SCS trials were offered at the end of the 7 day trial to experience stimulation using the OMG Connector.
  
  
  METHODS
  Academic university-based pain management center.
  
  
  METHODS
  Participants were trialed using the OMG Connector at the end of the 7 day spinal cord stimulation trial. Data based on participants' preference were collected.
  
  
  RESULTS
  The average pain score at baseline was 7.3 on a 10-point scale overall, with improvement during the SCS trial to 2.9 overall; 3.5 in Medtronic (MT); and 2.4 in St. Jude (SJ) SCS trials (P = 0.04). The average pain score with OMG was 2.6 overall; 2.8 in MT; and 2.4 in SJ (P = 0.28). In terms of overall coverage of pain distribution, paresthesia and overall satisfaction, the P values were 0.24, 0.21 and 0.33 respectively. Overall, 12 of 16 participants underwent permanent implantation. One of the 4 failed trials was successfully retrialed with the OMG Connector.
  
  
  CONCLUSIONS
  Small sample of participants and the duration of the OMG Connector trial.
  
  
  CONCLUSIONS
  The OMG Connector offers patients another opportunity to better access the available treatment options during the SCS trial period.
authors.affiliation: West Virginia University Department of Neurosurgery, Pain Division, Morgantown, WV 26506, USA. kimc@wvuhealthcare.com
authors.forename: Chong H
authors.initials: CH
authors.lastname: Kim
authors.forename: Mohammed A
authors.initials: MA
authors.lastname: Issa
authors.forename: Richard M
authors.initials: RM
authors.lastname: Vaglienti
mesh_terms: D000328:Adult; D000368:Aged; D059350:Chronic Pain / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000295:instrumentation / Q000379:methods; D015331:Cohort Studies; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D004582:Electronics, Medical / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010292:Paresthesia / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D012189:Retrospective Studies; D012646:Self Administration / Q000295:instrumentation* / Q000379:methods; D013116:Spinal Cord / Q000502:physiology / Q000601:surgery*