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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 : November 19, 2020
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.

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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 : April 2028
Estimated Study Completion Date : April 2028

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




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



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
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Contact: Alison Lewis 661-231-5168 Alison.Lewis@bsci.com
Contact: Diane Keesey (661) 949-4175 diane.keesey@bsci.com

Locations
Show Show 96 study locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Corporation
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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: November 19, 2020
Last Verified: November 2020
Keywords provided by Boston Scientific Corporation:
stimulation
implantable
pulse generator
back pain
chronic pain
leg pain