RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Last updated on April 2022Recruitment
- Recruitment Status
- Recruiting
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
- 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
Exclusion Criteria
- 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
- 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
- Contraindicated for Boston Scientific neurostimulation system
Summary
- Conditions
- Pain
- Type
- Observational
- Design
- Observational Model: Cohort
- Time Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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.
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
- 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
Exclusion Criteria
- 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
- 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
- Contraindicated for Boston Scientific neurostimulation system
Tracking Information
- NCT #
- NCT01719055
- Collaborators
- Not Provided
- Investigators
- Study Director: Roshini Jain Boston Scientific Corporation