RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
NCT ID: NCT01719055
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4800 participants
OBSERVATIONAL
2012-11-19
2035-05-31
Brief Summary
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\- and -
To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Boston Scientific SCS Systems
Subjects permanently implanted with a Boston Scientific neurostimulation systems
neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Interventions
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neurostimulation system
Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
Eligibility Criteria
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Inclusion Criteria
* Signed a valid, IRB/EC-approved informed consent form
* 18 years of age or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Physicians Research Group, LLC
Phoenix, Arizona, United States
Hope Research Institute
Phoenix, Arizona, 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
Denver Back Pain Specialists
Greenwood Village, Colorado, 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
Goodman Campbell Brain and Spine
Greenwood, Indiana, United States
American Health Network of Indiana, LLC
Muncie, Indiana, United States
Research Medical Center
Lenexa, Kansas, 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
Michigan Pain Specialists
Ann Arbor, Michigan, 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
Hope Research Institute
Las Vegas, Nevada, 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
Pacific Sports and Spine, LLC
Eugene, Oregon, United States
Fox Chase Pain Management
Trevose, Pennsylvania, 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
Institute of Precision Pain Medicine
Corpus Christi, 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
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, , Australia
Pain Matrix
Waurn Ponds, , Australia
Pain Medicine of South Australia
Wayville, , Australia
AZ Sint-Lucas
Ghent, , Belgium
AZ Delta
Roeselare, , Belgium
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
Uniklinik Köln
Cologne, , Germany
Uniklinik Köln
Cologne, , Germany
Universitaetsklinikum Dusseldorf
Düsseldorf, , 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, , Japan
Hyogo College of Medicine Hospital
Nishinomiya-shi, , Japan
Okayama University Hospital
Okayama, , Japan
Sakai Hospital Kinki University Faculty of Medicine
Sakaishi, , 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
H. Marques De Valdecilla
Santander, , Spain
Hospital Virgen De La Salud
Toledo, , Spain
Hospital General de Valencia
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Ospedale Regionale di Lugano
Viganello, , Switzerland
Basildon and Thurrock University Hospitals NHS
Basildon, , United Kingdom
Southmead Hospital Bristol
Bristol, , United Kingdom
The General Infirmary
Leeds, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
St. Bartholomews Hospital
London, , United Kingdom
Royal National Orthopaedic Hospital
Stanmore, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research Manager
Role: primary
Boston Scientific Clinical Research
Role: primary
References
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Rauck RL, Loudermilk E, Thomson SJ, Paz-Solis JF, Bojrab L, Noles J, Vesper J, Atallah J, Roth D, Hegarty J, Prud'Homme M, Phillips GM, Smith SG, Ibrahim M, Willoughby CD, Obray JB, Gupta M, Paez J, Berg AP, Harrison NJ, Maino P, Mambalam P, McCarty M, Towlerton G, Love-Jones S, Ahmed S, Lee A, Shah B, Goor-Aryeh I, Russo MA, Varela N, Phelps JB, Cid J, Fernandez T, Perez-Hernandez C, Keehn D, Rosenow JM, Haider N, Parrent AG, Lawrence MM, Georgius P, Demartini L, Mendiola A, Mehta V, Thoma R, Israel AF, Carolis G, Bhatia S, Green M, Villarreal A, Crooks MT, Gwinn RP, Pilitsis JG, Sato H, Vega SM, Hillegass MG, Carnes P, Scherer C, Brill S, Yu J, Brennan JJ, Gatzinsky K, Navani A, Snook LT Jr, Bujedo BM, Andres Ares J, Murillo A, Trobridge AT, Assil K, Shah J, McLeod C, Buwembo J, Coster O, Miller N, Sanapati M, Mikhael M, Przkora R, Sukenaga N, Raso LJ, Calodney AK, Caceres Jerez LE, Uchiyama T, Kallewaard JW, Chandler B, Piedimonte F, Candido KD, Weaver TE, Agari T, Holthouse D, Woon R, Patel N, Lechleiter K, Jain R. Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Pain Manag. 2023 Feb;13(2):115-127. doi: 10.2217/pmt-2022-0091. Epub 2023 Jan 24.
Other Identifiers
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90876777
Identifier Type: OTHER
Identifier Source: secondary_id
A7007
Identifier Type: -
Identifier Source: org_study_id