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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?

Pain

Study Interventions

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

Study Arms

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

Study Status

Recruiting

Start Date: May 2013

Completed Date: December 2020

Phase: N/A

Type: Observational

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01719055

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