Clinical trial NCT01719055: RELIEF - A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Official title: A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Keywords: stimulation
implantable
pulse generator
back pain
chronic pain
leg pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
measure: Percent Pain Relief
timeFrame: Up to 60 months follow up
measure: Percent Pain Relief
timeFrame: Up to 60 months follow up
measure: Percent Pain Relief
timeFrame: Up to 60 months follow up
measure: Change in QoL
timeFrame: Up to 60 months follow up
Locations:
city: Phoenix
country: United States
facility: Physicians Research Group, LLC
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
city: Campbell
country: United States
facility: Comprehensive Pain Management Center
state: California
city: Carlsbad
country: United States
facility: Coastal Research Institute
state: California
city: Fountain Valley
country: United States
facility: Pain Medicine Associates, Inc.
state: California
city: Sacramento
country: United States
facility: Metropolitan Pain Management Consultants Inc.
state: California
city: San Diego
country: United States
facility: Huntley Pain Specialists
state: California
city: Thousand Oaks
country: United States
facility: Conejo Pain Specialists
state: California
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Jupiter
country: United States
facility: Louis J. Raso, MD, PA
state: Florida
city: Miami Gardens
country: United States
facility: Advanced Interventional Pain Management and Research Clinic, Inc.
state: Florida
city: South Miami
country: United States
facility: JM Clinical Research
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, PA
state: Florida
city: Savannah
country: United States
facility: Orthopedic Research Foundation
state: Georgia
city: Stockbridge
country: United States
facility: Pain Care, LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic
state: Illinois
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Evansville
country: United States
facility: Global Scientific Innovations - Advanced Pain Care Clinic
state: Indiana
city: Fort Wayne
country: United States
facility: Summit Research Institute
state: Indiana
city: Greenwood
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Lenexa
country: United States
facility: Research Medical Center
state: Kansas
city: Crestview Hills
country: United States
facility: Neuroscience Associates of Northern Kentucky
state: Kentucky
city: Danville
country: United States
facility: Bux Pain Management
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brookline
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Pain Specialists
state: Michigan
city: Flint
country: United States
facility: Insight Institute of Neurosurgery & Neuroscience
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Anesthesia Pain Center, LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Midwest Pain Center
state: Missouri
city: Chesterfield
country: United States
facility: Saint Louis Pain Consultants
state: Missouri
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Las Vegas
country: United States
facility: Hope Research Institute
state: Nevada
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Utica
country: United States
facility: Spine and Skeletal Pain Medicine
state: New York
city: Huntersville
country: United States
facility: Carolinas Research Institute, PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Florence
country: United States
facility: Florence Neurosurgery and Spine
state: South Carolina
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Pawleys Island
country: United States
facility: Channel Research
state: South Carolina
city: Austin
country: United States
facility: Balcones Pain Consultants
state: Texas
city: North Richland Hills
country: United States
facility: Spine Works Institute
state: Texas
city: Rockwall
country: United States
facility: Spine Team Texas
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Bellevue
country: United States
facility: Washington Center for Pain Management
state: Washington
city: Kirkland
country: United States
facility: EvergreenHealth Pain Care
state: Washington
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Greenfield
country: United States
facility: Advanced Pain Management Appleton
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CENIT Centro de Neurociencias, Investigacion y Tratamiento
city: Auchenflower
country: Australia
facility: Interventus Pain Specialists
city: Broadmeadow
country: Australia
facility: Hunter Clinical Research
city: Broadmeadow
country: Australia
facility: Hunter Pain Clinic
city: Claremont
country: Australia
facility: Green Lizard Science
city: Hurstville
country: Australia
facility: Sydney Spine and Pain Pty Ltd
city: Noosa Heads
country: Australia
facility: Sunshine Coast Clinical Research
city: Waurn Ponds
country: Australia
facility: Pain Matrix
city: Wayville
country: Australia
facility: Pain Medicine of South Australia
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Roeselare
country: Belgium
facility: AZ Delta
city: London
country: Canada
facility: London Health Sciences Centre
city: Québec
country: Canada
facility: Hopital de Enfant-Jesus
city: Regina
country: Canada
facility: Regina General Hospital
city: Cali
country: Colombia
facility: Fundacion Clinica Valle del Lili
city: Floridablanca
country: Colombia
facility: Fundacion Cardiovascular de Colombia Floridablanca
city: Odense
country: Denmark
facility: Odense University Hospital
city: Berlin
country: Germany
facility: Universitatsklinik Charite Berlin
city: Bonn
country: Germany
facility: University KH Bonn
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Koeln
country: Germany
facility: Uniklinik Köln
city: Köln
country: Germany
facility: Uniklinik Köln
city: München
country: Germany
facility: Algesiologikum
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine Hospital
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Sakai-shi
country: Japan
facility: Sakai Hospital Kinki University Faculty of Medicine
city: Velp
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Elena
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: San Sebastián
country: Spain
facility: Hospital Donostia
city: Santander
country: Spain
facility: H. Marques De Valdecilla
city: Toledo
country: Spain
facility: Hospital Virgen De La Salud
city: Valencia
country: Spain
facility: Hospital General de Valencia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Viganello
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University Hospitals NHS
city: Bristol
country: United Kingdom
facility: Southmead Hospital Bristol
city: Leeds
country: United Kingdom
facility: The General Infirmary
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St. Bartholomews Hospital
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: