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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 : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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 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
Study Start Date : May 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Precision Plus
Subjects permanently implanted with a Boston Scientific Precision Plus neurostimulation system
Device: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome

Alternative Boston Scientific systems
Subjects permanently implanted with other 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




Primary Outcome Measures :
  1. Percent pain relief [ Time Frame: 6 months ]
    Subject-reported percent pain relief of targeted pain at 6 months post neurostimulation trial


Secondary Outcome Measures :
  1. Percent pain relief [ Time Frame: End of Neurostimulation Trial, 12, 24, and 36 months post neurostimulation trial ]
    Percent pain relief of targeted pain as reported by the Subject

  2. Change in pain intensity [ Time Frame: from Baseline to End of Neurostimulation Trial, 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in intensity of targeted pain as reported by the Subject

  3. Change in physical functioning [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in physical functioning as reported by the Subject

  4. Change in QoL [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in quality of life as reported by the Subject

  5. Global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]
    Clinical global impression as reported by the physician

  6. Subject global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]
    Subject global impression as reported by the Subject

  7. Depression [ Time Frame: from Baseline to 12 and 36 months post neurostimulation trial ]
    Change in depression as reported by the Subject

  8. Paresthesia Coverage [ Time Frame: End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ]
    Paresthesia coverage of targeted pain (a tingling sensation associated with neurostimulation therapy) as reported by the Subject

  9. Medications [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in the total amount of physician-prescribed, pain-related medications used

  10. Subject Satisfaction [ Time Frame: at End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ]
    Satisfaction with treatment as reported by the Subject

  11. Trial to Permanent Implantation [ Time Frame: 12 months ]
    Progression to permanent implantation with a Boston Scientific neurostimulation system by 12 months post neurostimulation trial

  12. Ease of Use [ Time Frame: 6 months ]
    Patient ease of use of the implanted system, as reported by the Subject


Other Outcome Measures:
  1. Work Productivity [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in employment as reported by the Subject

  2. Resource Utilization [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in medical resource utilization

  3. Adverse Events [ Time Frame: 36 months ]
    Rate of device-related and procedure-related Adverse Events (AEs) from trial lead insertion through completion of study

  4. Serious Adverse Events [ Time Frame: 36 months ]
    Rate of Serious Adverse Events (SAEs) from informed consent through completion of study



Information from the National Library of Medicine

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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

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
Contact: Ann Masuda, M.S. (661) 949-4726 Ann.Masuda@bsci.com
Contact: Diane Bowers (661) 949-4175 Diane.Bowers@bsci.com

Locations
United States, California
Boston Scientific Clinical Research Information Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Roshini Jain Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01719055     History of Changes
Other Study ID Numbers: A7007
90876777 ( Other Identifier: BSC protocol number )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Keywords provided by Boston Scientific Corporation:
stimulation
implantable
pulse generator
back pain
chronic pain
leg pain