Patient Retrospective Outcomes (PRO)

NCT ID: NCT01550575

Last Updated: 2025-11-13

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-03

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Non Boston Scientific Systems

Intervention Type DEVICE

Spinal cord stimulation, RF, IDS etc.

Boston Scientific Systems

Intervention Type DEVICE

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.

Non Boston Scientific Systems

Intervention Type DEVICE

Spinal cord stimulation, RF, IDS etc.

Boston Scientific Systems

Intervention Type DEVICE

Spinal cord stimulation, RF, IDS etc

Interventions

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Non Boston Scientific Systems

Spinal cord stimulation, RF, IDS etc.

Intervention Type DEVICE

Boston Scientific Systems

Spinal cord stimulation, RF, IDS etc

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

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Lakeside Spine & Pain

Lake Havasu City, Arizona, United States

Site Status RECRUITING

Hope Research Institute

Phoenix, Arizona, United States

Site Status COMPLETED

Kern Neuroscience Institute

Bakersfield, California, United States

Site Status COMPLETED

Pain Consultants of San Diego

Chula Vista, California, United States

Site Status COMPLETED

Pain Medicine Associates, Inc.

Fountain Valley, California, United States

Site Status WITHDRAWN

UCSD Medical Center - Jacobs Medical Center

La Jolla, California, United States

Site Status COMPLETED

California Orthopedics & Spine

Larkspur, California, United States

Site Status COMPLETED

MarinHealth Spine Institute

Larkspur, California, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Newport Beach Headache and Pain

Newport Beach, California, United States

Site Status COMPLETED

Vitamed Research

Rancho Mirage, California, United States

Site Status COMPLETED

Pacific Pain Management, Inc.

Ventura, California, United States

Site Status COMPLETED

IPM Medical Group Inc.

Walnut Creek, California, United States

Site Status COMPLETED

Barolat Neuroscience

Denver, Colorado, United States

Site Status COMPLETED

Advanced Diagnostic Pain Treatment Centers

New Haven, Connecticut, United States

Site Status COMPLETED

Orlando Health Neuroscience Institute

Clermont, Florida, United States

Site Status RECRUITING

Florida Spine Specialists

Fort Lauderdale, Florida, United States

Site Status COMPLETED

Louis J. Raso, MD, PA

Jupiter, Florida, United States

Site Status RECRUITING

Florida Pain Institute

Merritt Island, Florida, United States

Site Status COMPLETED

Advanced Interventional Pain Management and Research Clinic, Inc.

Miami Gardens, Florida, United States

Site Status COMPLETED

Florida Pain Clinic

Ocala, Florida, United States

Site Status RECRUITING

Orthomicrospine

Pensacola, Florida, United States

Site Status COMPLETED

HCA Florida West Orthopedic Specialists

Pensacola, Florida, United States

Site Status RECRUITING

West Florida Orthopedics and Spine Surgery

Pensacola, Florida, United States

Site Status COMPLETED

Interventional Spine and Pain Institute

Vero Beach, Florida, United States

Site Status RECRUITING

Orthopedic Research Foundation

Savannah, Georgia, United States

Site Status WITHDRAWN

Centurion Spine and Pain

Waycross, Georgia, United States

Site Status COMPLETED

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status COMPLETED

Pain and Spine Specialists of Idaho

Idaho Falls, Idaho, United States

Site Status RECRUITING

North Idaho Day Surgery

Post Falls, Idaho, United States

Site Status COMPLETED

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status COMPLETED

Summit Research Institute

Fort Wayne, Indiana, United States

Site Status COMPLETED

Comprehensive Pain and Spine Specialists

Muncie, Indiana, United States

Site Status RECRUITING

Henry Community Health

New Castle, Indiana, United States

Site Status RECRUITING

Precision Spine Care

Overland Park, Kansas, United States

Site Status COMPLETED

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, United States

Site Status RECRUITING

Pain and Spine Specialist of Maryland

Mount Airy, Maryland, United States

Site Status COMPLETED

Michigan Orthopedic Center

Lansing, Michigan, United States

Site Status RECRUITING

Multidisciplinary Pain Management Services

Okemos, Michigan, United States

Site Status RECRUITING

Forest Health Medical Center

Ypsilanti, Michigan, United States

Site Status RECRUITING

Twin Cities Pain Clinic & Surgery Center

Edina, Minnesota, United States

Site Status RECRUITING

NeuroSpecs-Gulfport Performance Spine

Gulfport, Mississippi, United States

Site Status COMPLETED

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, United States

Site Status COMPLETED

Saint Louis Pain Consultants

Chesterfield, Missouri, United States

Site Status COMPLETED

Mercy Medical Research Institute

Springfield, Missouri, United States

Site Status COMPLETED

Albany Medical Center

Albany, New York, United States

Site Status COMPLETED

Jeffrey M. Epstein, M.D. PC

Babylon, New York, United States

Site Status COMPLETED

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Spine and Skeletal Pain Medicine

Utica, New York, United States

Site Status COMPLETED

Integrative Pain and Wellness Associates

Williamsville, New York, United States

Site Status RECRUITING

Vidant Roanoke - Chowan Hospital Pain Center

Ahoskie, North Carolina, United States

Site Status COMPLETED

Carolinas Research Institute, PLLC

Huntersville, North Carolina, United States

Site Status COMPLETED

Crystal Coast Pain Management

New Bern, North Carolina, United States

Site Status RECRUITING

Piedmont Interventional Pain Care

Salisbury, North Carolina, United States

Site Status RECRUITING

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Interventional Pain and Spine

Cincinnati, Ohio, United States

Site Status RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status RECRUITING

Orthopaedic and Spine Center

Dublin, Ohio, United States

Site Status WITHDRAWN

Cincinnati Comprehensive Pain Center

Fairfield, Ohio, United States

Site Status COMPLETED

Western Reserve Spine and Pain Institute

Kent, Ohio, United States

Site Status COMPLETED

Interventional Pain Consultants

Toledo, Ohio, United States

Site Status RECRUITING

Toledo Clinic

Toledo, Ohio, United States

Site Status COMPLETED

University of Toledo Medical Center

Toledo, Ohio, United States

Site Status COMPLETED

Pacific Sports and Spine, LLC

Eugene, Oregon, United States

Site Status RECRUITING

Pain Specialists of Southern Oregon

Medford, Oregon, United States

Site Status RECRUITING

Quave Clinic

Medford, Oregon, United States

Site Status COMPLETED

Southern Oregon Orthopedics

Medford, Oregon, United States

Site Status RECRUITING

Summit Spine

Portland, Oregon, United States

Site Status COMPLETED

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status COMPLETED

Florence Neurosurgery and Spine

Florence, South Carolina, United States

Site Status COMPLETED

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, United States

Site Status RECRUITING

Interventional Spine and Pain Center

Manchester, Tennessee, United States

Site Status COMPLETED

Comprehensive Pain & Neurology Center

Murfreesboro, Tennessee, United States

Site Status RECRUITING

Pain Center Physicians

Austin, Texas, United States

Site Status COMPLETED

Balcones Pain Consultants

Austin, Texas, United States

Site Status COMPLETED

KSF Orthopaedics

Houston, Texas, United States

Site Status RECRUITING

Central Texas Pain Institute

Killeen, Texas, United States

Site Status COMPLETED

Advanced Spine Pain Solutions

Laredo, Texas, United States

Site Status RECRUITING

Spine Team Texas

Southlake, Texas, United States

Site Status COMPLETED

Space City Pain Specialists

Webster, Texas, United States

Site Status COMPLETED

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Site Status COMPLETED

EvergreenHealth Pain Care

Kirkland, Washington, United States

Site Status COMPLETED

Mind Your Body Institute

Seattle, Washington, United States

Site Status COMPLETED

Northwest Pain Care

Spokane, Washington, United States

Site Status COMPLETED

West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status COMPLETED

Interventional Pain Specialists of Wisconsin

Rice Lake, Wisconsin, United States

Site Status COMPLETED

Berwick Pain Management

Berwick, , Australia

Site Status COMPLETED

Hunter Pain Clinic

Broadmeadow, , Australia

Site Status COMPLETED

Monash Clinical Research

Caulfield South, , Australia

Site Status COMPLETED

Green Lizard Science

Claremont, , Australia

Site Status COMPLETED

Sydney Spine and Pain Pty Ltd

Hurstville, , Australia

Site Status COMPLETED

Sunshine Coast Clinical Research

Noosa, , Australia

Site Status COMPLETED

Womens Health and Research Institute of Australia

Sydney, , Australia

Site Status COMPLETED

Pain Medicine of South Australia

Wayville, , Australia

Site Status ACTIVE_NOT_RECRUITING

Clinique Saint-Pierre Ottignies

Ottignies, , Belgium

Site Status RECRUITING

Polyclinique du Parc

Caen, , France

Site Status RECRUITING

Clinique de la Sauvegarde

Lyon, , France

Site Status COMPLETED

Hopital Prive du Confluent SAS

Nantes, , France

Site Status RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status RECRUITING

CHU La Miletrie

Poitiers, , France

Site Status RECRUITING

CHU de Nantes-Hopital Laennec

Saint-Herblain, , France

Site Status RECRUITING

Hopital Foch

Suresnes, , France

Site Status COMPLETED

Inter Neuro

Berlin, , Germany

Site Status RECRUITING

Uniklinik Kƶln

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

Site Status RECRUITING

St. Marien-Hospital Hamm

Hamm, , Germany

Site Status RECRUITING

University Berlin, Charite Virchow Standort, Wedding

Wedding, , Germany

Site Status RECRUITING

Pres. Osp. Civile Santi Antonio e Biagio

Alessandria, , Italy

Site Status RECRUITING

Az. Osp. Monaldi

Napoli, , Italy

Site Status RECRUITING

AUSL della Romagna

Ravenna, , Italy

Site Status RECRUITING

Ospedale San Giuliano

Rionero in Vulture, , Italy

Site Status RECRUITING

Ospedale S. Giovanni Addolorata

Rome, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, , Italy

Site Status RECRUITING

Alrijne Ziekenhuis Leiderdorp

Leiderdorp, , Netherlands

Site Status COMPLETED

Ziekenhuis Rijnstate

Velp, , Netherlands

Site Status RECRUITING

CHU Sao Joao

Porto, , Portugal

Site Status RECRUITING

Ponce Interventional Pain Center

Ponce, , Puerto Rico

Site Status COMPLETED

Hospital De Bellvitge

Barcelona, , Spain

Site Status RECRUITING

H. Puerta Del Mar

Cadiz, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Cartagena

Cartagena, , Spain

Site Status RECRUITING

Hospital Universitario Doctor Jose Molina Orosa

Las Palmas, , Spain

Site Status RECRUITING

Hospital San Pedro

LogroƱo, , Spain

Site Status RECRUITING

Fundacion Jimenez Diaz

Madrid, , Spain

Site Status COMPLETED

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital La Paz

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Quiron Madrid

Madrid, , Spain

Site Status RECRUITING

Hospital Puerta de Hierro

Majadahonda, , Spain

Site Status RECRUITING

Complexo Hospitalario Universitario de Ourense (CHUO)

Ourense, , Spain

Site Status RECRUITING

Hospital Virgen Del Rocio

Seville, , Spain

Site Status COMPLETED

H. Clinico Universitario

Valencia, , Spain

Site Status RECRUITING

Hospital de la Ribera

Valencia, , Spain

Site Status RECRUITING

Hospital Universitario La Fe

Valencia, , Spain

Site Status RECRUITING

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status COMPLETED

La Tour Hospital

Meyrin, , Switzerland

Site Status COMPLETED

Ospedale Regionale di Lugano

Viganello, , Switzerland

Site Status RECRUITING

Basildon and Thurrock University Hospitals NHS

Basildon, , United Kingdom

Site Status RECRUITING

Southmead Hospital Bristol

Bristol, , United Kingdom

Site Status RECRUITING

Royal Devon & Exeter Hospital

Exeter, , United Kingdom

Site Status RECRUITING

The General Infirmary

Leeds, , United Kingdom

Site Status RECRUITING

St. Bartholomews Hospital

London, , United Kingdom

Site Status RECRUITING

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium France Germany Italy Netherlands Portugal Puerto Rico Spain Sweden Switzerland United Kingdom

Central Contacts

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Alison Lewis

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Cleo Mertz

Role: CONTACT

Phone: 855-213-9890

Email: [email protected]

Facility Contacts

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Boston Scientific Clinical Research

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Boston Scientific Clinical Research

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Boston Scientific Clinical Research

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References

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Ferro R, North J, Kranenburg A, Pyles S, Dorenkamp C, Poston J, Schneider J, Auten K, Goldberg E. Automated Neural Dosing for Fast-Acting Subperception Therapy: Sustained Spinal Cord Stimulation Outcomes from a Multicenter Study. Pain Ther. 2025 Aug;14(4):1417-1429. doi: 10.1007/s40122-025-00758-y. Epub 2025 Jul 3.

Reference Type DERIVED
PMID: 40603812 (View on PubMed)

Metzger C, Hammond B, Ferro R, North J, Pyles S, Kranenburg A, Washabaugh E, Goldberg E. Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States. Expert Rev Med Devices. 2025 Jan-Feb;22(2):155-164. doi: 10.1080/17434440.2025.2453554. Epub 2025 Jan 16.

Reference Type DERIVED
PMID: 39819320 (View on PubMed)

Other Identifiers

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A7005

Identifier Type: -

Identifier Source: org_study_id