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

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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

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 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.

Details

Full study title RELIEF: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain. -- Sub-study NAVITAS: A Study to Characterize the Relationship between Select Objective Metrics and Clinical Outcomes in Chronic Pain Patients treated with Boston Scientific Neurostimulation Systems
Protocol number OCR18338
ClinicalTrials.gov ID NCT01719055

Eligibility

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

Lead researcher

  • Rene Przkora, MD, PhD, FASA
    Anesthesiologist, Pain Medicine Specialist
    Rene Przkora

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.