RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (RELIEF)

May 8, 2026 updated by: Boston Scientific Corporation

A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain

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 Instructions for Use

- and -

To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, multi-center, global, post-market study 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

Enrollment (Estimated)

4800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Terminated
        • CENIT Centro de Neurociencias, Investigacion y Tratamiento
  • Australia
      • Auchenflower, Australia
        • Withdrawn
        • Interventus Pain Specialists
      • Broadmeadow, Australia
        • Terminated
        • Hunter Clinical Research
      • Broadmeadow, Australia
        • Terminated
        • Hunter Pain Clinic
      • Claremont, Australia
        • Terminated
        • Green Lizard Science
      • Hurstville, Australia
        • Terminated
        • Sydney Spine and Pain Pty Ltd
      • Noosa, Australia
        • Terminated
        • Sunshine Coast Clinical Research
      • Waurn Ponds, Australia
        • Terminated
        • Pain Matrix
      • Wayville, Australia
        • Recruiting
        • Pain Medicine of South Australia
        • Contact:
  • Belgium
      • Ghent, Belgium
        • Withdrawn
        • AZ Sint-Lucas
      • Roeselare, Belgium
        • Terminated
        • AZ Delta
  • Canada
      • London, Canada
        • Terminated
        • London Health Sciences Centre
      • Québec, Canada
        • Recruiting
        • Hopital de Enfant-Jesus
        • Contact:
      • Regina, Canada
        • Recruiting
        • Regina General Hospital
        • Contact:
  • Colombia
      • Cali, Colombia
        • Withdrawn
        • Fundacion Clinica Valle del Lili
      • Floridablanca, Colombia
        • Terminated
        • Fundacion Cardiovascular de Colombia Floridablanca
  • Denmark
      • Odense, Denmark
        • Terminated
        • Odense University Hospital
  • Germany
      • Berlin, Germany
        • Recruiting
        • Universitatsklinik Charite Berlin
        • Contact:
      • Bonn, Germany
        • Terminated
        • University KH Bonn
      • Cologne, Germany
        • Recruiting
        • Uniklinik Koln
        • Contact:
      • Cologne, Germany
        • Terminated
        • Uniklinik Koln
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • München, Germany
        • Terminated
        • Algesiologikum
  • Israel
      • Ramat Gan, Israel
        • Terminated
        • Sheba Medical Center
      • Tel Aviv, Israel
        • Terminated
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Pavia, Italy
        • Recruiting
        • Fondazione Salvatore Maugeri IRCCS
        • Contact:
      • Pisa, Italy
        • Terminated
        • Azienda Ospedaliero Universitaria Pisana
  • Japan
      • Kobe, Japan
        • Terminated
        • Kobe University Hospital
      • Nishinomiya-shi, Japan
        • Terminated
        • Hyogo College of Medicine Hospital
      • Okayama, Japan
        • Terminated
        • Okayama University Hospital
      • Sakaishi, Japan
        • Terminated
        • Sakai Hospital Kinki University Faculty of Medicine
  • Netherlands
      • Velp, Netherlands
        • Terminated
        • Ziekenhuis Rijnstate
  • Spain
      • Ciudad Real, Spain
        • Recruiting
        • Hospital General de Ciudad Real
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Puerta de Hierro
        • Contact:
      • Madrid, Spain
        • Withdrawn
        • Hospital Universitario Infanta Elena
      • Madrid, Spain
        • Terminated
        • Hospital La Paz
      • Madrid, Spain
        • Terminated
        • Hospital La Princesa
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
      • San Sebastián, Spain
        • Active, not recruiting
        • Hospital Donostia
      • Santander, Spain
        • Terminated
        • H. Marques De Valdecilla
      • Toledo, Spain
        • Terminated
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Recruiting
        • Hospital General de Valencia
        • Contact:
  • Sweden
      • Gothenburg, Sweden
        • Terminated
        • Sahlgrenska University Hospital
  • Switzerland
      • Viganello, Switzerland
        • Terminated
        • Ospedale Regionale di Lugano
  • United Kingdom
      • Basildon, United Kingdom
        • Recruiting
        • Basildon and Thurrock University Hospitals NHS
        • Contact:
      • Bristol, United Kingdom
        • Recruiting
        • Southmead Hospital Bristol
        • Contact:
      • Leeds, United Kingdom
        • Recruiting
        • The General Infirmary
        • Contact:
      • London, United Kingdom
        • Recruiting
        • St. Bartholomews Hospital
        • Contact:
      • London, United Kingdom
        • Terminated
        • Chelsea and Westminster Hospital
      • Middlesbrough, United Kingdom
        • Recruiting
        • James Cook University Hospital
        • Contact:
      • Stanmore, United Kingdom
        • Terminated
        • Royal National Orthopaedic Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Terminated
        • HOPE Research Institute
      • Phoenix, Arizona, United States, 85016
        • Terminated
        • Physicians Research Group, LLC
      • Tucson, Arizona, United States, 85724
        • Completed
        • Banner University Medical Center
    • California
      • Campbell, California, United States, 95008
        • Terminated
        • Comprehensive Pain Management Center
      • Carlsbad, California, United States, 92009
        • Terminated
        • Coastal Research Institute
      • Fountain Valley, California, United States, 92708
        • Terminated
        • Pain Medicine Associates, Inc.
      • Sacramento, California, United States, 95821
        • Terminated
        • Metropolitan Pain Management Consultants Inc.
      • San Diego, California, United States, 92108
        • Withdrawn
        • Huntley Pain Specialists
      • Thousand Oaks, California, United States, 91362
        • Terminated
        • Conejo Pain Specialists
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Recruiting
        • Denver Back Pain Specialists
        • Contact:
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • South Lake Pain Institute, Inc
        • Contact:
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Orlando Health Neuroscience Institute, Inc
        • Contact:
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Shands Hospital
        • Contact:
      • Jupiter, Florida, United States, 33477
        • Terminated
        • Louis J. Raso, MD, PA
      • Miami Gardens, Florida, United States, 33169
        • Terminated
        • Advanced Interventional Pain Management and Research Clinic, Inc.
      • South Miami, Florida, United States, 33143
        • Withdrawn
        • JM Clinical Research
      • Tallahassee, Florida, United States, 32308
        • Terminated
        • Tallahassee Neurological Clinic, PA
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Terminated
        • Orthopedic Research Foundation
      • Stockbridge, Georgia, United States, 30281
        • Withdrawn
        • Pain Care, LLC
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Terminated
        • Chicago Anesthesia Pain Specialists
      • Chicago, Illinois, United States, 60611
        • Terminated
        • Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Terminated
        • Global Scientific Innovations - Advanced Pain Care Clinic
      • Fort Wayne, Indiana, United States, 46825
        • Terminated
        • Summit Research Institute
      • Greenwood, Indiana, United States, 46143
        • Withdrawn
        • Goodman Campbell Brain and Spine
      • Muncie, Indiana, United States, 47304
        • Terminated
        • American Health Network of Indiana, LLC
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Terminated
        • Research Medical Center
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Withdrawn
        • Neuroscience Associates of Northern Kentucky
      • Danville, Kentucky, United States, 40422
        • Terminated
        • Bux Pain Management
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Willis-Knighton River Cities Clinical Research Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
      • Brookline, Massachusetts, United States, 02445
        • Terminated
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • Recruiting
        • Michigan Pain Specialists
        • Contact:
      • Flint, Michigan, United States, 48507
        • Terminated
        • Insight Institute of Neurosurgery & Neuroscience
      • Ypsilanti, Michigan, United States, 48198
        • Terminated
        • Forest Health Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Terminated
        • Jackson Anesthesia Pain Center, LLC
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Terminated
        • Midwest Pain Center
      • Chesterfield, Missouri, United States, 63017
        • Terminated
        • Saint Louis Pain Consultants
      • Lee's Summit, Missouri, United States, 64086
        • Terminated
        • KC Pain Centers
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Withdrawn
        • HOPE Research Institute
    • New York
      • Albany, New York, United States, 12208
        • Terminated
        • Albany Medical Center
      • New York, New York, United States, 10065
        • Terminated
        • New York Presbyterian Hospital
      • Rochester, New York, United States, 14618
        • Terminated
        • University of Rochester
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
      • Utica, New York, United States, 13502
        • Terminated
        • Spine and Skeletal Pain Medicine
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Terminated
        • Carolinas Research Institute, PLLC
      • Raleigh, North Carolina, United States, 27607
        • Terminated
        • Raleigh Neurology Associates, P.A.
      • Winston-Salem, North Carolina, United States, 27103
        • Terminated
        • The Center for Clinical Research, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Completed
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43203
        • Terminated
        • Ohio State University Medical Center
      • Toledo, Ohio, United States, 43614
        • Terminated
        • University of Toledo Medical Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Pacific Sports and Spine, LLC
        • Contact:
    • Pennsylvania
      • Trevose, Pennsylvania, United States, 19053
        • Recruiting
        • Fox Chase Pain Management
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Terminated
        • Medical University of South Carolina
      • Florence, South Carolina, United States, 29506
        • Terminated
        • Florence Neurosurgery and Spine
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • PCPMG Clinical Research Unit, LLC
        • Contact:
      • Pawleys Island, South Carolina, United States, 29585
        • Terminated
        • Channel Research
    • Texas
      • Austin, Texas, United States, 78745
        • Terminated
        • Balcones Pain Consultants
      • Corpus Christi, Texas, United States, 78414
        • Recruiting
        • Institute of Precision Pain Medicine
        • Contact:
      • North Richland Hills, Texas, United States, 76182
        • Terminated
        • Spine Works Institute
      • Rockwall, Texas, United States, 75032
        • Terminated
        • Spine Team Texas
      • Tyler, Texas, United States, 75701
        • Terminated
        • Precision Spine Care
    • Washington
      • Bellevue, Washington, United States, 98004
        • Terminated
        • Washington Center for Pain Management
      • Kirkland, Washington, United States, 98034
        • Withdrawn
        • EvergreenHealth Pain Care
      • Seattle, Washington, United States, 98122
        • Terminated
        • Swedish Neuroscience Institute
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Withdrawn
        • West Virginia University Hospitals
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53221
        • Terminated
        • Advanced Pain Management Appleton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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 Instructions for Use, as applicable in each country or region

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Pain Relief
Time Frame: Up to 60 months follow up
Percent pain relief of targeted pain at 6, 12, 24, 36, 48, and 60 months follow up
Up to 60 months follow up
Percent Pain Relief
Time Frame: Up to 60 months follow up
Percent pain relief of low back pain at 6, 12, 24, 36, 48, and 60 months follow up
Up to 60 months follow up
Percent Pain Relief
Time Frame: Up to 60 months follow up
Percent pain relief of leg pain at 6, 12, 24, 36, 48, and 60 months follow up
Up to 60 months follow up
Change in QoL
Time Frame: Up to 60 months follow up
Change in quality of life as reported by the Subject at
Up to 60 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2012

Primary Completion (Estimated)

May 1, 2035

Study Completion (Estimated)

May 1, 2035

Study Registration Dates

First Submitted

October 30, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimated)

November 1, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7007
  • 90876777 (Other Identifier: BSC protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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