Pain | RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Pain research study
What is the primary objective of this study?
To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Directions for Use - and - To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
Who is eligible to participate?
Key Inclusion Criteria: - Study candidate is scheduled to be trialed, on-label, with a commercially approved Boston Scientific neurostimulation system for pain, per local directions for use - Signed a valid, IRB/EC-approved informed consent form - 18 years of age or older Key Exclusion Criteria: - Contraindicated for Boston Scientific neurostimulation system - Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:neurostimulation systemTrial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Precision PlusSubjects permanently implanted with a Boston Scientific Precision Plus neurostimulation system
Alternative Boston Scientific systemsSubjects permanently implanted with other Boston Scientific neurostimulation systems
Start Date: May 2013
Completed Date: December 2020
Primary Outcome: Percent pain relief
Secondary Outcome: Percent pain relief
Study sponsors, principal investigator, and references
Principal Investigator: Roshini Jain
Lead Sponsor: Boston Scientific Corporation