Clinical trial NCT01550575: Patient Retrospective Outcomes (PRO)
Official title: Patient Retrospective Outcomes (PRO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have previously been implanted with, or who are candidates for implantation with a spinal cord stimulation system or other various treatment approaches, such as radio frequency ablation or indirect decompression system (IDS).

Brief summary: This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

Detailed description: This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Eligibility criteria: Key Inclusion Criteria:

* Previously treated with or eligible for use with Boston Scientific Systems
* 18 years of age or older at the start of Baseline

Primary outcomes:
measure: Responder rate
timeFrame: Through study completion, approximately two years
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Havasu City
country: United States
facility: Lakeside Spine & Pain
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Bakersfield
country: United States
facility: Kern Neuroscience Institute
state: California
city: Chula Vista
country: United States
facility: Pain Consultants of San Diego
state: California
city: Fountain Valley
country: United States
facility: Pain Medicine Associates, Inc.
state: California
city: La Jolla
country: United States
facility: UCSD Medical Center - Jacobs Medical Center
state: California
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: Larkspur
country: United States
facility: MarinHealth Spine Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Newport Beach
country: United States
facility: Newport Beach Headache and Pain
state: California
city: Rancho Mirage
country: United States
facility: Vitamed Research
state: California
city: Ventura
country: United States
facility: Pacific Pain Management, Inc.
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group Inc.
state: California
city: Denver
country: United States
facility: Barolat Neuroscience
state: Colorado
city: New Haven
country: United States
facility: Advanced Diagnostic Pain Treatment Centers
state: Connecticut
city: Clermont
country: United States
facility: South Lake Pain Institute, Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Florida Spine Specialists
state: Florida
city: Jupiter
country: United States
facility: Louis J. Raso, MD, PA
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Miami Gardens
country: United States
facility: Advanced Interventional Pain Management and Research Clinic, Inc.
state: Florida
city: Ocala
country: United States
facility: Florida Pain Clinic
state: Florida
city: Pensacola
country: United States
facility: Orthomicrospine
state: Florida
city: Pensacola
country: United States
facility: HCA Florida West Orthopedic Specialists
state: Florida
city: Pensacola
country: United States
facility: West Florida Orthopedics and Spine Surgery
state: Florida
city: Vero Beach
country: United States
facility: Interventional Spine and Pain Institute
state: Florida
city: Savannah
country: United States
facility: Orthopedic Research Foundation
state: Georgia
city: Waycross
country: United States
facility: Centurion Spine and Pain
state: Georgia
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Idaho Falls
country: United States
facility: Pain and Spine Specialists of Idaho
state: Idaho
city: Post Falls
country: United States
facility: North Idaho Day Surgery
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Summit Research Institute
state: Indiana
city: New Castle
country: United States
facility: Henry Community Health
state: Indiana
city: Overland Park
country: United States
facility: Precision Spine Care
state: Kansas
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Clinical Research Center
state: Louisiana
city: Mount Airy
country: United States
facility: Pain and Spine Specialist of Maryland
state: Maryland
city: Lansing
country: United States
facility: Michigan Orthopedic Center
state: Michigan
city: Okemos
country: United States
facility: Multidisciplinary Pain Management Services
state: Michigan
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Edina
country: United States
facility: Twin Cities Pain Clinic & Surgery Center
state: Minnesota
city: Gulfport
country: United States
facility: NeuroSpecs-Gulfport Performance Spine
state: Mississippi
city: Pascagoula
country: United States
facility: Comprehensive Pain & Rehabilitation
state: Mississippi
city: Chesterfield
country: United States
facility: Saint Louis Pain Consultants
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Babylon
country: United States
facility: Jeffrey M. Epstein, M.D. PC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Utica
country: United States
facility: Spine and Skeletal Pain Medicine
state: New York
city: Williamsville
country: United States
facility: Integrative Pain and Wellness Associates
state: New York
city: Ahoskie
country: United States
facility: Vidant Roanoke - Chowan Hospital Pain Center
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas Research Institute, PLLC
state: North Carolina
city: New Bern
country: United States
facility: Crystal Coast Pain Management
state: North Carolina
city: Salisbury
country: United States
facility: Piedmont Interventional Pain Care
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Interventional Pain and Spine
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Dublin
country: United States
facility: Orthopaedic and Spine Center
state: Ohio
city: Fairfield
country: United States
facility: Cincinnati Comprehensive Pain Center
state: Ohio
city: Kent
country: United States
facility: Western Reserve Spine and Pain Institute
state: Ohio
city: Toledo
country: United States
facility: Interventional Pain Consultants
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
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: Medford
country: United States
facility: Pain Specialists of Southern Oregon
state: Oregon
city: Medford
country: United States
facility: Quave Clinic
state: Oregon
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
city: Portland
country: United States
facility: Summit Spine
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
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: Manchester
country: United States
facility: Interventional Spine and Pain Center
state: Tennessee
city: Murfreesboro
country: United States
facility: Comprehensive Pain & Neurology Center
state: Tennessee
city: Austin
country: United States
facility: Pain Center Physicians
state: Texas
city: Austin
country: United States
facility: Balcones Pain Consultants
state: Texas
city: Houston
country: United States
facility: KSF Orthopaedics
state: Texas
city: Killeen
country: United States
facility: Central Texas Pain Institute
state: Texas
city: Laredo
country: United States
facility: Advanced Spine Pain Solutions
state: Texas
city: Southlake
country: United States
facility: Spine Team Texas
state: Texas
city: Webster
country: United States
facility: Space City Pain Specialists
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedic Center
state: Utah
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Kirkland
country: United States
facility: EvergreenHealth Pain Care
state: Washington
city: Seattle
country: United States
facility: Mind Your Body Institute
state: Washington
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
city: Rice Lake
country: United States
facility: Interventional Pain Specialists of Wisconsin
state: Wisconsin
city: Berwick
country: Australia
facility: Berwick Pain Management
city: Broadmeadow
country: Australia
facility: Hunter Pain Clinic
city: Caulfield South
country: Australia
facility: Monash Clinical Research
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: Sydney
country: Australia
facility: Womens Health and Research Institute of Australia
city: Wayville
country: Australia
facility: Pain Medicine of South Australia
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre Ottignies
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Nantes
country: France
facility: Hopital Prive du Confluent SAS
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Poitiers
country: France
facility: CHU La Miletrie
city: Saint-Herblain
country: France
facility: CHU de Nantes-Hopital Laennec
city: Suresnes
country: France
facility: Hopital Foch
city: Berlin-Wedding
country: Germany
facility: University Berlin, Charite Virchow Standort, Wedding
city: Berlin
country: Germany
facility: Inter Neuro
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Hamm
country: Germany
facility: St. Marien-Hospital Hamm
city: Alessandria
country: Italy
facility: Pres. Osp. Civile Santi Antonio e Biagio
city: Napoli
country: Italy
facility: Az. Osp. Monaldi
city: Ravenna
country: Italy
facility: AUSL della Romagna
city: Rionero In Vulture
country: Italy
facility: Ospedale San Giuliano
city: Rome
country: Italy
facility: Ospedale S. Giovanni Addolorata
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis Leiderdorp
city: Velp
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Porto
country: Portugal
facility: CHU Sao Joao
city: Ponce
country: Puerto Rico
facility: Ponce Interventional Pain Center
city: Barcelona
country: Spain
facility: Hospital De Bellvitge
city: Cadiz
country: Spain
facility: H. Puerta Del Mar
city: Cartagena
country: Spain
facility: Complejo Hospitalario Universitario de Cartagena
city: Las Palmas
country: Spain
facility: Hospital Universitario Doctor Jose Molina Orosa
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Quiron Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Orense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense (CHUO)
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
city: Valencia
country: Spain
facility: H. Clinico Universitario
city: Valencia
country: Spain
facility: Hospital de la Ribera
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Goeteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Meyrin
country: Switzerland
facility: La Tour 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: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: Leeds
country: United Kingdom
facility: The General Infirmary
city: London
country: United Kingdom
facility: St. Bartholomews Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: