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Trial record 1 of 1 for:    NCT01719055
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RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF)

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ClinicalTrials.gov Identifier: NCT01719055
Recruitment Status : Recruiting
First Posted : November 1, 2012
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment
Pain Device: neurostimulation system

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 4800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Actual Study Start Date : November 19, 2012
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Boston Scientific SCS Systems
Subjects permanently implanted with a Boston Scientific neurostimulation systems
 Device: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome


Outcome Measures
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Other Outcome Measures:
  1. Percent pain relief [ Time Frame: up to 36 months follow up ]
    Percent pain relief of targeted pain at 6, 12, 24 and 36 months follow up

  2. Percent pain relief [ Time Frame: up to 36 months follow up ]
    Percent pain relief of low back pain at 6, 12, 24 and 36 months follow up

  3. Percent pain relief [ Time Frame: up to 36 months follow up ]
    Percent pain relief of leg pain at 6, 12, 24 and 36 months follow up

  4. Change in QoL [ Time Frame: up to 36 months follow up ]
    Change in quality of life as reported by the Subject at 6, 12, 24 and 36 months follow up


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Directions for Use, as applicable in each country or region
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719055


Contacts
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Contact: Gerard Herro, MS 855-213-9890 BSNClinicalTrials@bsci.com
Contact: Diane Keesey 855-213-9890 BSNClinicalTrials@bsci.com

Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01719055    
Other Study ID Numbers: A7007
90876777 ( Other Identifier: BSC protocol number )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Keywords provided by Boston Scientific Corporation:
stimulation
implantable
pulse generator
 back pain
chronic pain
leg pain