RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
- Conditions
- Pain
- Interventions
- Device: neurostimulation system
- Registration Number
- NCT01719055
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4800
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Boston Scientific SCS Systems neurostimulation system Subjects permanently implanted with a Boston Scientific neurostimulation systems
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (110)
Research Medical Center
🇺🇸Lenexa, Kansas, United States
H. Marques De Valdecilla
🇪🇸Santander, Spain
Hospital Virgen De La Salud
🇪🇸Toledo, Spain
Hospital General de Valencia
🇪🇸Valencia, Spain
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Ospedale Regionale di Lugano
🇨🇭Viganello, Switzerland
Southmead Hospital Bristol
🇬🇧Bristol, United Kingdom
The General Infirmary
🇬🇧Leeds, United Kingdom
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
Goodman Campbell Brain and Spine
🇺🇸Greenwood, Indiana, United States
American Health Network of Indiana, LLC
🇺🇸Muncie, Indiana, United States
Michigan Pain Specialists
🇺🇸Ann Arbor, Michigan, United States
Physicians Research Group, LLC
🇺🇸Phoenix, Arizona, United States
Hope Research Institute
🇺🇸Las Vegas, Nevada, United States
Banner University Medical Center
🇺🇸Tucson, Arizona, United States
Comprehensive Pain Management Center
🇺🇸Campbell, California, United States
Coastal Research Institute
🇺🇸Carlsbad, California, United States
Pain Medicine Associates, Inc.
🇺🇸Fountain Valley, California, United States
Metropolitan Pain Management Consultants Inc.
🇺🇸Sacramento, California, United States
Huntley Pain Specialists
🇺🇸San Diego, California, United States
Conejo Pain Specialists
🇺🇸Thousand Oaks, California, United States
South Lake Pain Institute, Inc
🇺🇸Clermont, Florida, United States
University of Florida Shands Hospital
🇺🇸Gainesville, Florida, United States
Louis J. Raso, MD, PA
🇺🇸Jupiter, Florida, United States
Advanced Interventional Pain Management and Research Clinic, Inc.
🇺🇸Miami Gardens, Florida, United States
JM Clinical Research
🇺🇸South Miami, Florida, United States
Tallahassee Neurological Clinic, PA
🇺🇸Tallahassee, Florida, United States
Orthopedic Research Foundation
🇺🇸Savannah, Georgia, United States
Pain Care, LLC
🇺🇸Stockbridge, Georgia, United States
Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic
🇺🇸Chicago, Illinois, United States
Chicago Anesthesia Pain Specialists
🇺🇸Chicago, Illinois, United States
Global Scientific Innovations - Advanced Pain Care Clinic
🇺🇸Evansville, Indiana, United States
Summit Research Institute
🇺🇸Fort Wayne, Indiana, United States
Neuroscience Associates of Northern Kentucky
🇺🇸Crestview Hills, Kentucky, United States
Bux Pain Management
🇺🇸Danville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Willis-Knighton River Cities Clinical Research Center
🇺🇸Shreveport, Louisiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Brookline, Massachusetts, United States
Insight Institute of Neurosurgery & Neuroscience
🇺🇸Flint, Michigan, United States
Forest Health Medical Center
🇺🇸Ypsilanti, Michigan, United States
Jackson Anesthesia Pain Center, LLC
🇺🇸Jackson, Mississippi, United States
Midwest Pain Center
🇺🇸Chesterfield, Missouri, United States
Saint Louis Pain Consultants
🇺🇸Chesterfield, Missouri, United States
KC Pain Centers
🇺🇸Lee's Summit, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Spine and Skeletal Pain Medicine
🇺🇸Utica, New York, United States
Carolinas Research Institute, PLLC
🇺🇸Huntersville, North Carolina, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
The Center for Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
St. Bartholomews Hospital
🇬🇧London, United Kingdom
Pacific Sports and Spine, LLC
🇺🇸Eugene, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Florence Neurosurgery and Spine
🇺🇸Florence, South Carolina, United States
PCPMG Clinical Research Unit, LLC
🇺🇸Greenville, South Carolina, United States
Channel Research
🇺🇸Pawleys Island, South Carolina, United States
Balcones Pain Consultants
🇺🇸Austin, Texas, United States
Spine Works Institute
🇺🇸North Richland Hills, Texas, United States
Spine Team Texas
🇺🇸Rockwall, Texas, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States
Washington Center for Pain Management
🇺🇸Bellevue, Washington, United States
EvergreenHealth Pain Care
🇺🇸Kirkland, Washington, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Advanced Pain Management Appleton
🇺🇸Greenfield, Wisconsin, United States
CENIT Centro de Neurociencias, Investigacion y Tratamiento
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Interventus Pain Specialists
🇦🇺Auchenflower, Australia
Hunter Clinical Research
🇦🇺Broadmeadow, Australia
Hunter Pain Clinic
🇦🇺Broadmeadow, Australia
Green Lizard Science
🇦🇺Claremont, Australia
Sydney Spine and Pain Pty Ltd
🇦🇺Hurstville, Australia
Sunshine Coast Clinical Research
🇦🇺Noosa Heads, Australia
Pain Matrix
🇦🇺Waurn Ponds, Australia
Pain Medicine of South Australia
🇦🇺Wayville, Australia
AZ Sint-Lucas
🇧🇪Gent, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Basildon and Thurrock University Hospitals NHS
🇬🇧Basildon, United Kingdom
London Health Sciences Centre
🇨🇦London, Canada
Hopital de Enfant-Jesus
🇨🇦Québec, Canada
Regina General Hospital
🇨🇦Regina, Canada
Fundacion Clinica Valle del Lili
🇨🇴Cali, Colombia
Fundacion Cardiovascular de Colombia Floridablanca
🇨🇴Floridablanca, Colombia
Odense University Hospital
🇩🇰Odense, Denmark
Universitatsklinik Charite Berlin
🇩🇪Berlin, Germany
University KH Bonn
🇩🇪Bonn, Germany
Universitaetsklinikum Dusseldorf
🇩🇪Duesseldorf, Germany
Uniklinik Köln
🇩🇪Köln, Germany
Algesiologikum
🇩🇪München, Germany
Sheba Medical Center
🇮🇱Ramat-Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Fondazione Salvatore Maugeri IRCCS
🇮🇹Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
Kobe University Hospital
🇯🇵Kobe-shi, Japan
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya-shi, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Japan
Sakai Hospital Kinki University Faculty of Medicine
🇯🇵Sakai-shi, Japan
Ziekenhuis Rijnstate
🇳🇱Velp, Netherlands
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Universitario Infanta Elena
🇪🇸Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Donostia
🇪🇸San Sebastián, Spain
Royal National Orthopaedic Hospital
🇬🇧Stanmore, United Kingdom