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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01719055
First received: October 30, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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 Intervention
Pain
Device: neurostimulation system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Percent pain relief [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Subject-reported percent pain relief of targeted pain at 6 months post neurostimulation trial


Secondary Outcome Measures:
  • Percent pain relief [ Time Frame: End of Neurostimulation Trial, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Percent pain relief of targeted pain as reported by the Subject

  • Change in pain intensity [ Time Frame: from Baseline to End of Neurostimulation Trial, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in intensity of targeted pain as reported by the Subject

  • Change in physical functioning [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in physical functioning as reported by the Subject

  • Change in QoL [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in quality of life as reported by the Subject

  • Global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Clinical global impression as reported by the physician

  • Subject global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Subject global impression as reported by the Subject

  • Depression [ Time Frame: from Baseline to 12 and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in depression as reported by the Subject

  • Paresthesia Coverage [ Time Frame: End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Paresthesia coverage of targeted pain (a tingling sensation associated with neurostimulation therapy) as reported by the Subject

  • Medications [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in the total amount of physician-prescribed, pain-related medications used

  • Subject Satisfaction [ Time Frame: at End of neurostimulation trial, IPG implantation, 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Satisfaction with treatment as reported by the Subject

  • Trial to Permanent Implantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Progression to permanent implantation with a Boston Scientific neurostimulation system by 12 months post neurostimulation trial

  • Ease of Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient ease of use of the implanted system, as reported by the Subject


Other Outcome Measures:
  • Work Productivity [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in employment as reported by the Subject

  • Resource Utilization [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ] [ Designated as safety issue: No ]
    Change in medical resource utilization

  • Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Rate of device-related and procedure-related Adverse Events (AEs) from trial lead insertion through completion of study

  • Serious Adverse Events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    Rate of Serious Adverse Events (SAEs) from informed consent through completion of study


Estimated Enrollment: 4800
Study Start Date: May 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Ph.D. Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01719055     History of Changes
Other Study ID Numbers: A7007, 90876777
Study First Received: October 30, 2012
Last Updated: October 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014