Patient Retrospective Outcomes (PRO) (PRO)

April 5, 2024 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

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

  • Australia
      • Berwick, Australia
        • Recruiting
        • Berwick Pain Management
        • Contact:
      • Broadmeadow, Australia
        • Recruiting
        • Hunter Pain Clinic
        • Contact:
      • Caulfield South, Australia
        • Recruiting
        • Monash Clinical Research
        • Contact:
      • Claremont, Australia
        • Recruiting
        • Green Lizard Science
        • Contact:
      • Hurstville, Australia
        • Recruiting
        • Sydney Spine and Pain Pty Ltd
        • Contact:
      • Noosa Heads, Australia
        • Recruiting
        • Sunshine Coast Clinical Research
        • Contact:
      • Sydney, Australia
        • Recruiting
        • Womens Health and Research Institute of Australia
        • Contact:
      • Wayville, Australia
        • Recruiting
        • Pain Medicine of South Australia
        • Contact:
  • France
      • Lyon, France
        • Recruiting
        • Clinique de la Sauvegarde
        • Contact:
      • Paris, France
        • Recruiting
        • Fondation Ophtalmologique Adolphe de Rothschild
        • Contact:
      • Poitiers, France
        • Recruiting
        • CHU La Milétrie
        • Contact:
      • Saint-Herblain, France
        • Recruiting
        • CHU de Nantes-Hopital Laennec
        • Contact:
      • Suresnes, France
        • Recruiting
        • Hôpital FOCH
        • Contact:
  • Germany
      • Berlin-Wedding, Germany
        • Recruiting
        • University Berlin, Charite Virchow Standort, Wedding
        • Contact:
      • Cologne, Germany
        • Recruiting
        • Uniklinik Köln
        • Contact:
      • Duesseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • Hamm, Germany
        • Recruiting
        • St. Marien-Hospital Hamm
        • Contact:
  • Italy
      • Alessandria, Italy
        • Recruiting
        • Pres. Osp. Civile Santi Antonio e Biagio
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Az. Osp. Monaldi
        • Contact:
      • Rionero In Vulture, Italy
        • Recruiting
        • Ospedale San Giuliano
        • Contact:
      • Rome, Italy, 30326
        • Recruiting
        • Ospedale S. Giovanni Addolorata
        • Contact:
  • Netherlands
      • Leiderdorp, Netherlands
        • Recruiting
        • Alrijne Ziekenhuis Leiderdorp
        • Contact:
      • Velp, Netherlands
        • Recruiting
        • Ziekenhuis Rijnstate
        • Contact:
  • Puerto Rico
      • Ponce, Puerto Rico, 716
        • Completed
        • Ponce Interventional Pain Center
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital de Bellvitge
        • Contact:
      • Logroño, Spain
        • Recruiting
        • Hospital San Pedro
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital La Paz
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Fundacion Jimenez Diaz
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Quiron Madrid
        • Contact:
      • Sevilla, Spain
        • Recruiting
        • Hospital Virgen del Rocío
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
      • Valencia, Spain
        • Recruiting
        • H. Clinico Universitario
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Hospital de La Ribera
        • Contact:
  • Sweden
      • Goeteborg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:
  • Switzerland
      • Meyrin, Switzerland
        • Recruiting
        • La Tour Hospital
        • Contact:
      • Viganello, Switzerland
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:
  • 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:
      • Middlesbrough, United Kingdom
        • Recruiting
        • James Cook University Hospital
        • Contact:
  • United States
    • Arizona
      • Lake Havasu City, Arizona, United States, 86403
        • Recruiting
        • Lakeside Spine & Pain
        • Contact:
      • Phoenix, Arizona, United States, 85018
        • Completed
        • Hope Research Institute
    • California
      • Bakersfield, California, United States, 93306
        • Completed
        • Kern Neuroscience Institute
      • Chula Vista, California, United States, 91914
        • Completed
        • Pain Consultants of San Diego
      • Fountain Valley, California, United States, 92708
        • Withdrawn
        • Pain Medicine Associates, Inc.
      • La Jolla, California, United States, 92037
        • Completed
        • UCSD Medical Center - Jacobs Medical Center
      • Larkspur, California, United States, 94939
        • Completed
        • California Orthopedics & Spine
      • Newport Beach, California, United States, 92660
        • Completed
        • Newport Beach Headache and Pain
      • Rancho Mirage, California, United States, 92270
        • Completed
        • Vitamed Research
      • Ventura, California, United States, 93003
        • Completed
        • Pacific Pain Management, Inc.
      • Walnut Creek, California, United States, 94598
        • Completed
        • IPM Medical Group Inc.
    • Colorado
      • Denver, Colorado, United States, 80218
        • Completed
        • Barolat Neuroscience
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Completed
        • Advanced Diagnostic Pain Treatment Centers
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • South Lake Pain Institute, Inc
        • Contact:
      • Fort Lauderdale, Florida, United States, 33308
        • Completed
        • Florida Spine Specialists
      • Jupiter, Florida, United States, 33477
        • Recruiting
        • Louis J. Raso, MD, PA
        • Contact:
      • Merritt Island, Florida, United States, 32953
        • Completed
        • Florida Pain Institute
      • Miami Gardens, Florida, United States, 33169
        • Completed
        • Advanced Interventional Pain Management and Research Clinic, Inc.
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Florida Pain Clinic
        • Contact:
      • Pensacola, Florida, United States, 32503
        • Completed
        • Orthomicrospine
      • Pensacola, Florida, United States, 32514
        • Recruiting
        • HCA Florida West Orthopedic Specialists
        • Contact:
      • Pensacola, Florida, United States, 32514
        • Completed
        • West Florida Orthopedics and Spine Surgery
      • Vero Beach, Florida, United States, 32960
        • Recruiting
        • Interventional Spine and Pain Institute
        • Contact:
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Withdrawn
        • Orthopedic Research Foundation
      • Waycross, Georgia, United States, 31522
        • Completed
        • Centurion Spine and Pain
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Completed
        • Tripler Army Medical Center
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Pain and Spine Specialists of Idaho
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Completed
        • North Idaho Day Surgery
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • Northwestern Memorial Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Completed
        • Summit Research Institute
      • New Castle, Indiana, United States, 47362
        • Recruiting
        • Henry Community Health
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Completed
        • Precision Spine Care
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Willis-Knighton River Cities Clinical Research Center
        • Contact:
    • Maryland
      • Mount Airy, Maryland, United States, 21771
        • Completed
        • Pain and Spine Specialist of Maryland
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Michigan Orthopedic Center
        • Contact:
      • Okemos, Michigan, United States, 48864
        • Recruiting
        • Multidisciplinary Pain Management Services
        • Contact:
      • Ypsilanti, Michigan, United States, 48198
        • Recruiting
        • Forest Health Medical Center
        • Contact:
    • Minnesota
      • Edina, Minnesota, United States, 55439
        • Recruiting
        • Twin Cities Pain Clinic & Surgery Center
        • Contact:
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Completed
        • NeuroSpecs-Gulfport Performance Spine
      • Pascagoula, Mississippi, United States, 39581
        • Completed
        • Comprehensive Pain & Rehabilitation
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Saint Louis Pain Consultants
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Completed
        • Mercy Medical Research Institute
    • New York
      • Albany, New York, United States, 12208
        • Completed
        • Albany Medical Center
      • Babylon, New York, United States, 11702
        • Completed
        • Jeffrey M. Epstein, M.D. PC
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
      • Utica, New York, United States, 13502
        • Completed
        • Spine and Skeletal Pain Medicine
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Integrative Pain and Wellness Associates
        • Contact:
    • North Carolina
      • Ahoskie, North Carolina, United States, 27910
        • Completed
        • Vidant Roanoke - Chowan Hospital Pain Center
      • Huntersville, North Carolina, United States, 28078
        • Completed
        • Carolinas Research Institute, PLLC
      • New Bern, North Carolina, United States, 28560
        • Recruiting
        • Crystal Coast Pain Management
        • Contact:
      • Salisbury, North Carolina, United States, 28147
        • Recruiting
        • Piedmont Interventional Pain Care
        • Contact:
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • The Center for Clinical Research, LLC
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Withdrawn
        • Orthopaedic and Spine Center
      • Fairfield, Ohio, United States, 45014
        • Completed
        • Cincinnati Comprehensive Pain Center
      • Kent, Ohio, United States, 44240
        • Completed
        • Western Reserve Spine and Pain Institute
      • Toledo, Ohio, United States, 43623
        • Completed
        • University of Toledo Medical Center
      • Toledo, Ohio, United States, 43623
        • Completed
        • Toledo Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Pacific Sports and Spine, LLC
        • Contact:
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Southern Oregon Orthopedics
        • Contact:
      • Medford, Oregon, United States, 97504
        • Completed
        • Quave Clinic
      • Portland, Oregon, United States, 97225
        • Completed
        • Summit Spine
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Completed
        • Geisinger Medical Center
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • Completed
        • Florence Neurosurgery and Spine
    • Tennessee
      • Manchester, Tennessee, United States, 37355
        • Active, not recruiting
        • Interventional Spine and Pain Center
      • Murfreesboro, Tennessee, United States, 37128
        • Recruiting
        • Comprehensive Pain & Neurology Center
        • Contact:
    • Texas
      • Austin, Texas, United States, 78704
        • Completed
        • Pain Center Physicians
      • Austin, Texas, United States, 78750
        • Completed
        • Balcones Pain Consultants
      • Houston, Texas, United States, 77090
        • Recruiting
        • KSF Orthopaedics
        • Contact:
      • Killeen, Texas, United States, 76542
        • Completed
        • Central Texas Pain Institute
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Advanced Spine Pain Solutions
        • Contact:
      • Southlake, Texas, United States, 76092
        • Completed
        • Spine Team Texas
      • Webster, Texas, United States, 77598
        • Completed
        • Space City Pain Specialists
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Completed
        • Carilion Roanoke Memorial Hospital
    • Washington
      • Kirkland, Washington, United States, 98034
        • Completed
        • EvergreenHealth Pain Care
      • Seattle, Washington, United States, 98115
        • Completed
        • Mind Your Body Institute
      • Spokane, Washington, United States, 99201
        • Recruiting
        • Northwest Pain Care
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Completed
        • West Virginia University Hospitals
    • Wisconsin
      • Rice Lake, Wisconsin, United States, 54868
        • Completed
        • Interventional Pain Specialists of Wisconsin

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

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).

Description

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

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: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients eligible for SCS, RF or other treatment approaches
Patients who have previously been implanted with, or are eligible for implantation with a spinal cord stimulation system or various other treatment approaches such as RF, IDS, etc.
Device: Non Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc.
Device: Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc
Patients Eligible for treatment options with prior treatment
Patients who have previously been implanted with a spinal cord stimulation system or other various treatments, and have thereafter received a different form of chronic pain treatment such as a different SCS system, RF, IDS etc.
Device: Non Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc.
Device: Boston Scientific Systems
Spinal cord stimulation, RF, IDS etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: Through study completion, approximately two years
Responder rate for pain relief through study completion.
Through study completion, approximately two years

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 Neuromodulation Corporation

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)

April 3, 2012

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimated)

March 12, 2012

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7005

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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