Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01719055
Recruitment Status : Recruiting
First Posted : November 1, 2012
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date October 30, 2012
First Posted Date November 1, 2012
Last Update Posted Date September 11, 2019
Study Start Date May 2013
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2012)
Percent pain relief [ Time Frame: 6 months ]
Subject-reported percent pain relief of targeted pain at 6 months post neurostimulation trial
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01719055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 31, 2012)
  • 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
  • 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
  • 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
  • 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
  • Global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]
    Clinical global impression as reported by the physician
  • Subject global impression [ Time Frame: 6, 12, 24, and 36 months post neurostimulation trial ]
    Subject global impression as reported by the Subject
  • Depression [ Time Frame: from Baseline to 12 and 36 months post neurostimulation trial ]
    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 ]
    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 ]
    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 ]
    Satisfaction with treatment as reported by the Subject
  • Trial to Permanent Implantation [ Time Frame: 12 months ]
    Progression to permanent implantation with a Boston Scientific neurostimulation system by 12 months post neurostimulation trial
  • Ease of Use [ Time Frame: 6 months ]
    Patient ease of use of the implanted system, as reported by the Subject
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 31, 2012)
  • Work Productivity [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in employment as reported by the Subject
  • Resource Utilization [ Time Frame: from Baseline to 6, 12, 24, and 36 months post neurostimulation trial ]
    Change in medical resource utilization
  • Adverse Events [ Time Frame: 36 months ]
    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 ]
    Rate of Serious Adverse Events (SAEs) from informed consent through completion of study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Official Title A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
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

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Pain
Intervention Device: neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Study Groups/Cohorts
  • Precision Plus
    Subjects permanently implanted with a Boston Scientific Precision Plus neurostimulation system
    Intervention: Device: neurostimulation system
  • Alternative Boston Scientific systems
    Subjects permanently implanted with other Boston Scientific neurostimulation systems
    Intervention: Device: neurostimulation system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 31, 2012)
4800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ann Masuda, M.S. (661) 949-4726 Ann.Masuda@bsci.com
Contact: Diane Bowers (661) 949-4175 Diane.Bowers@bsci.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01719055
Other Study ID Numbers A7007
90876777 ( Other Identifier: BSC protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor Boston Scientific Corporation
Collaborators Not Provided
Investigators
Study Director: Roshini Jain Boston Scientific Corporation
PRS Account Boston Scientific Corporation
Verification Date September 2019