NCT01550575

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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
14 countries

144 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Apr 2012Dec 2030

First Submitted

Initial submission to the registry

March 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

April 3, 2012

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

18.7 years

First QC Date

March 5, 2012

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Responder rate

    Responder rate for pain relief through study completion.

    Through study completion, approximately two years

Study Arms (2)

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 SystemsDevice: Boston Scientific Systems

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 SystemsDevice: Boston Scientific Systems

Interventions

Spinal cord stimulation, RF, IDS etc.

Patients Eligible for treatment options with prior treatmentPatients eligible for SCS, RF or other treatment approaches

Spinal cord stimulation, RF, IDS etc

Patients Eligible for treatment options with prior treatmentPatients eligible for SCS, RF or other treatment approaches

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (144)

Lakeside Spine & Pain

Lake Havasu City, Arizona, 86403, United States

RECRUITING

Hope Research Institute

Phoenix, Arizona, 85018, United States

COMPLETED

Kern Neuroscience Institute

Bakersfield, California, 93306, United States

COMPLETED

Pain Consultants of San Diego

Chula Vista, California, 91914, United States

COMPLETED

Pain Medicine Associates, Inc.

Fountain Valley, California, 92708, United States

WITHDRAWN

UCSD Medical Center - Jacobs Medical Center

La Jolla, California, 92037, United States

COMPLETED

California Orthopedics & Spine

Larkspur, California, 94939, United States

COMPLETED

MarinHealth Spine Institute

Larkspur, California, 94939, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Newport Beach Headache and Pain

Newport Beach, California, 92660, United States

COMPLETED

Vitamed Research

Rancho Mirage, California, 92270, United States

COMPLETED

Pacific Pain Management, Inc.

Ventura, California, 93003, United States

COMPLETED

IPM Medical Group Inc.

Walnut Creek, California, 94598, United States

COMPLETED

Barolat Neuroscience

Denver, Colorado, 80218, United States

COMPLETED

Advanced Diagnostic Pain Treatment Centers

New Haven, Connecticut, 06511, United States

COMPLETED

Orlando Health Neuroscience Institute

Clermont, Florida, 34711, United States

RECRUITING

Florida Spine Specialists

Fort Lauderdale, Florida, 33308, United States

COMPLETED

Louis J. Raso, MD, PA

Jupiter, Florida, 33477, United States

RECRUITING

Florida Pain Institute

Merritt Island, Florida, 32953, United States

COMPLETED

Advanced Interventional Pain Management and Research Clinic, Inc.

Miami Gardens, Florida, 33169, United States

COMPLETED

Florida Pain Clinic

Ocala, Florida, 34471, United States

RECRUITING

Orthomicrospine

Pensacola, Florida, 32503, United States

COMPLETED

HCA Florida West Orthopedic Specialists

Pensacola, Florida, 32514, United States

RECRUITING

West Florida Orthopedics and Spine Surgery

Pensacola, Florida, 32514, United States

COMPLETED

Interventional Spine and Pain Institute

Vero Beach, Florida, 32960, United States

RECRUITING

Orthopedic Research Foundation

Savannah, Georgia, 31405, United States

WITHDRAWN

Centurion Spine and Pain

Waycross, Georgia, 31522, United States

COMPLETED

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

COMPLETED

Pain and Spine Specialists of Idaho

Idaho Falls, Idaho, 83404, United States

RECRUITING

North Idaho Day Surgery

Post Falls, Idaho, 83854, United States

COMPLETED

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

COMPLETED

Summit Research Institute

Fort Wayne, Indiana, 46825, United States

COMPLETED

Comprehensive Pain and Spine Specialists

Muncie, Indiana, 47304, United States

RECRUITING

Henry Community Health

New Castle, Indiana, 47362, United States

RECRUITING

Precision Spine Care

Overland Park, Kansas, 66211, United States

COMPLETED

Willis-Knighton River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

RECRUITING

Pain and Spine Specialist of Maryland

Mount Airy, Maryland, 21771, United States

COMPLETED

Michigan Orthopedic Center

Lansing, Michigan, 48910, United States

RECRUITING

Multidisciplinary Pain Management Services

Okemos, Michigan, 48864, United States

RECRUITING

Forest Health Medical Center

Ypsilanti, Michigan, 48198, United States

COMPLETED

Twin Cities Pain Clinic & Surgery Center

Edina, Minnesota, 55439, United States

COMPLETED

NeuroSpecs-Gulfport Performance Spine

Gulfport, Mississippi, 39503, United States

COMPLETED

Comprehensive Pain & Rehabilitation

Pascagoula, Mississippi, 39581, United States

COMPLETED

Saint Louis Pain Consultants

Chesterfield, Missouri, 63017, United States

COMPLETED

Mercy Medical Research Institute

Springfield, Missouri, 65804, United States

COMPLETED

Albany Medical Center

Albany, New York, 12208, United States

COMPLETED

Jeffrey M. Epstein, M.D. PC

Babylon, New York, 11702, United States

COMPLETED

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Spine and Skeletal Pain Medicine

Utica, New York, 13502, United States

COMPLETED

Integrative Pain and Wellness Associates

Williamsville, New York, 14221, United States

RECRUITING

Vidant Roanoke - Chowan Hospital Pain Center

Ahoskie, North Carolina, 27910, United States

COMPLETED

Carolinas Research Institute, PLLC

Huntersville, North Carolina, 28078, United States

COMPLETED

Crystal Coast Pain Management

New Bern, North Carolina, 28560, United States

RECRUITING

Piedmont Interventional Pain Care

Salisbury, North Carolina, 28147, United States

COMPLETED

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Interventional Pain and Spine

Cincinnati, Ohio, 45202, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Orthopaedic and Spine Center

Dublin, Ohio, 43016, United States

WITHDRAWN

Cincinnati Comprehensive Pain Center

Fairfield, Ohio, 45014, United States

COMPLETED

Western Reserve Spine and Pain Institute

Kent, Ohio, 44240, United States

COMPLETED

Interventional Pain Consultants

Toledo, Ohio, 43623, United States

RECRUITING

Toledo Clinic

Toledo, Ohio, 43623, United States

COMPLETED

University of Toledo Medical Center

Toledo, Ohio, 43623, United States

COMPLETED

Pacific Sports and Spine, LLC

Eugene, Oregon, 97401, United States

RECRUITING

Pain Specialists of Southern Oregon

Medford, Oregon, 97504, United States

RECRUITING

Quave Clinic

Medford, Oregon, 97504, United States

COMPLETED

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

RECRUITING

Summit Spine

Portland, Oregon, 97225, United States

COMPLETED

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

COMPLETED

Florence Neurosurgery and Spine

Florence, South Carolina, 29506, United States

COMPLETED

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

RECRUITING

Interventional Spine and Pain Center

Manchester, Tennessee, 37355, United States

COMPLETED

Comprehensive Pain & Neurology Center

Murfreesboro, Tennessee, 37128, United States

RECRUITING

Pain Center Physicians

Austin, Texas, 78704, United States

COMPLETED

Balcones Pain Consultants

Austin, Texas, 78750, United States

COMPLETED

KSF Orthopaedics

Houston, Texas, 77090, United States

RECRUITING

Central Texas Pain Institute

Killeen, Texas, 76542, United States

COMPLETED

Advanced Spine Pain Solutions

Laredo, Texas, 78041, United States

RECRUITING

Spine Team Texas

Southlake, Texas, 76092, United States

COMPLETED

Space City Pain Specialists

Webster, Texas, 77598, United States

COMPLETED

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

RECRUITING

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

COMPLETED

EvergreenHealth Pain Care

Kirkland, Washington, 98034, United States

COMPLETED

Mind Your Body Institute

Seattle, Washington, 98115, United States

COMPLETED

Northwest Pain Care

Spokane, Washington, 99201, United States

COMPLETED

West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

COMPLETED

Interventional Pain Specialists of Wisconsin

Rice Lake, Wisconsin, 54868, United States

COMPLETED

Berwick Pain Management

Berwick, Australia

COMPLETED

Hunter Pain Clinic

Broadmeadow, Australia

COMPLETED

Monash Clinical Research

Caulfield South, Australia

COMPLETED

Green Lizard Science

Claremont, Australia

COMPLETED

Sydney Spine and Pain Pty Ltd

Hurstville, Australia

COMPLETED

Sunshine Coast Clinical Research

Noosa, Australia

COMPLETED

Womens Health and Research Institute of Australia

Sydney, Australia

COMPLETED

Pain Medicine of South Australia

Wayville, Australia

COMPLETED

Clinique Saint-Pierre Ottignies

Ottignies, Belgium

RECRUITING

Polyclinique du Parc

Caen, France

RECRUITING

Clinique de la Sauvegarde

Lyon, France

COMPLETED

Hopital Prive du Confluent SAS

Nantes, France

RECRUITING

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

RECRUITING

CHU La Miletrie

Poitiers, France

RECRUITING

CHU de Nantes-Hopital Laennec

Saint-Herblain, France

RECRUITING

Hopital Foch

Suresnes, France

COMPLETED

Inter Neuro

Berlin, Germany

RECRUITING

Uniklinik Köln

Cologne, Germany

RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

RECRUITING

St. Marien-Hospital Hamm

Hamm, Germany

RECRUITING

University Berlin, Charite Virchow Standort, Wedding

Wedding, Germany

RECRUITING

Pres. Osp. Civile Santi Antonio e Biagio

Alessandria, Italy

RECRUITING

Az. Osp. Monaldi

Naples, Italy

RECRUITING

AUSL della Romagna

Ravenna, Italy

RECRUITING

Ospedale San Giuliano

Rionero in Vulture, Italy

RECRUITING

Ospedale S. Giovanni Addolorata

Rome, 30326, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

RECRUITING

Alrijne Ziekenhuis Leiderdorp

Leiderdorp, Netherlands

COMPLETED

Ziekenhuis Rijnstate

Velp, Netherlands

RECRUITING

CHU Sao Joao

Porto, Portugal

RECRUITING

Ponce Interventional Pain Center

Ponce, 716, Puerto Rico

COMPLETED

Hospital De Bellvitge

Barcelona, Spain

RECRUITING

H. Puerta Del Mar

Cadiz, Spain

RECRUITING

Complejo Hospitalario Universitario de Cartagena

Cartagena, Spain

RECRUITING

Hospital Universitario Doctor Jose Molina Orosa

Las Palmas, Spain

RECRUITING

Hospital San Pedro

Logroño, Spain

RECRUITING

Fundacion Jimenez Diaz

Madrid, Spain

COMPLETED

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

Hospital La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Quiron Madrid

Madrid, Spain

RECRUITING

Hospital Puerta de Hierro

Majadahonda, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense (CHUO)

Ourense, Spain

RECRUITING

Hospital Virgen Del Rocio

Seville, Spain

COMPLETED

H. Clinico Universitario

Valencia, Spain

RECRUITING

Hospital de la Ribera

Valencia, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

COMPLETED

La Tour Hospital

Meyrin, Switzerland

COMPLETED

Ospedale Regionale di Lugano

Viganello, Switzerland

RECRUITING

Izmir Bakircay Üniversitesi

Izmir, Turkey (Türkiye)

RECRUITING

Basildon and Thurrock University Hospitals NHS

Basildon, United Kingdom

RECRUITING

Southmead Hospital Bristol

Bristol, United Kingdom

RECRUITING

Royal Devon & Exeter Hospital

Exeter, United Kingdom

RECRUITING

The General Infirmary

Leeds, United Kingdom

RECRUITING

St. Bartholomews Hospital

London, United Kingdom

RECRUITING

James Cook University Hospital

Middlesbrough, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natalie Bloom Lyons

    Boston Scientific Neuromodulation Corporation

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 12, 2012

Study Start

April 3, 2012

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations