RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

• Percent pain relief [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Subject-reported percent pain relief of targeted pain at 6 months post neurostimulation trial
  
  

• Percent pain relief [ Time Frame: End of Neurostimulation Trial, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Percent pain relief of targeted pain as reported by the Subject
  
  
• Change in pain intensity [ Time Frame: from Baseline to End of Neurostimulation Trial, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in intensity of targeted pain as reported by the Subject
  
  
• Change in physical functioning [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in physical functioning as reported by the Subject
  
  
• Change in QoL [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in quality of life as reported by the Subject
  
  
• Global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Clinical global impression as reported by the physician
  
  
• Subject global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Subject global impression as reported by the Subject
  
  
• Depression [ Time Frame: from Baseline to 12 and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in depression as reported by the Subject
  
  
• Paresthesia Coverage [ Time Frame: End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Paresthesia coverage of targeted pain (a tingling sensation associated with neurostimulation therapy) as reported by the Subject
  
  
• Medications [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in the total amount of physician-prescribed, pain-related medications used
  
  
• Subject Satisfaction [ Time Frame: at End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Satisfaction with treatment as reported by the Subject
  
  
• Trial to Permanent Implantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  Progression to permanent implantation with a Boston Scientific neurostimulation system by 12 months post neurostimulation trial
  
  
• Ease of Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Patient ease of use of the implanted system, as reported by the Subject
  
  

• Work Productivity [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in employment as reported by the Subject
  
  
• Resource Utilization [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
  Change in medical resource utilization
  
  
• Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  Rate of device-related and procedure-related Adverse Events (AEs) from trial lead insertion through completion of study
  
  
• Serious Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  Rate of Serious Adverse Events (SAEs) from informed consent through completion of study
  
  

The study is a prospective, multi-center, global registry of Boston Scientific neurostimulation systems for pain.

The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.