Evaluating 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
Run by Boston Scientific Corporation · NCT01719055 · Data updated 2026-11-12
This study is testing how well Boston Scientific's neurostimulation therapy works for managing pain over the long term in people who have had a positive trial with the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4800 (estimated) |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 118 sites (Phoenix, Arizona and 117 other locations) |
| Status | Recruiting |
| Started | November 19, 2012 |
| Main results expected | May 2035 |
| Study ends | May 2035 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT01719055 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled to trial a commercially approved Boston Scientific neurostimulation system for pain.
✕Probably not a fit
Patients with contraindications for the neurostimulation system or those with cognitive impairments that affect their ability to assess pain relief will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study is a global, prospective observational registry that aims to gather real-world clinical outcomes of Boston Scientific's neurostimulation systems for pain management. It will assess the long-term effectiveness, economic value, and technical performance of these systems when used in routine clinical practice. Participants who respond positively to a trial of the neurostimulation therapy may receive a permanent implant, with treatment tailored to individual patient needs based on clinical discretion. The study will involve multiple centers and will adhere to established inclusion and exclusion criteria.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of neurostimulation therapy, potentially improving pain management strategies for patients.
How similar studies have gone: Other studies have shown success with similar neurostimulation approaches, indicating a promising avenue for pain management.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Denver Back Pain Specialists
Greenwood Village, Colorado, United States Recruiting -
Orlando Health Neuroscience Institute, Inc
Clermont, Florida, United States Recruiting -
South Lake Pain Institute, Inc
Clermont, Florida, United States Recruiting -
University of Florida Shands Hospital
Gainesville, Florida, United States Recruiting -
Ochsner Clinic Foundation
New Orleans, Louisiana, United States Recruiting -
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States Recruiting
Show 44 more locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Montefiore Medical Center
The Bronx, New York, United States Recruiting -
Pacific Sports and Spine, LLC
Eugene, Oregon, United States Recruiting -
Fox Chase Pain Management
Trevose, Pennsylvania, United States Recruiting -
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States Recruiting -
Institute of Precision Pain Medicine
Corpus Christi, Texas, United States Recruiting -
Pain Medicine of South Australia
Wayville, Australia Recruiting -
Hopital de Enfant-Jesus
Québec, Canada Recruiting -
Regina General Hospital
Regina, Canada Recruiting -
Universitatsklinik Charite Berlin
Berlin, Germany Recruiting -
Uniklinik Köln
Cologne, Germany Recruiting -
Universitaetsklinikum Dusseldorf
Düsseldorf, Germany Recruiting -
Fondazione Salvatore Maugeri IRCCS
Pavia, Italy Recruiting -
Hospital General de Ciudad Real
Ciudad Real, Spain Recruiting -
Hospital Puerta de Hierro
Madrid, Spain Recruiting -
Clinica Universidad de Navarra
Pamplona, Spain Recruiting -
Hospital General de Valencia
Valencia, Spain Recruiting -
Basildon and Thurrock University Hospitals NHS
Basildon, United Kingdom Recruiting -
Southmead Hospital Bristol
Bristol, 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 -
Physicians Research Group, LLC
Phoenix, Arizona, United States Terminated -
Hope Research Institute
Phoenix, Arizona, United States Terminated -
Banner University Medical Center
Tucson, Arizona, United States Completed -
Comprehensive Pain Management Center
Campbell, California, United States Terminated -
Coastal Research Institute
Carlsbad, California, United States Terminated -
Pain Medicine Associates, Inc.
Fountain Valley, California, United States Terminated -
Metropolitan Pain Management Consultants Inc.
Sacramento, California, United States Terminated -
Huntley Pain Specialists
San Diego, California, United States Withdrawn -
Conejo Pain Specialists
Thousand Oaks, California, United States Terminated -
Louis J. Raso, MD, PA
Jupiter, Florida, United States Terminated -
Advanced Interventional Pain Management and Research Clinic, Inc.
Miami Gardens, Florida, United States Terminated -
JM Clinical Research
South Miami, Florida, United States Withdrawn -
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, United States Terminated -
Orthopedic Research Foundation
Savannah, Georgia, United States Terminated -
Pain Care, LLC
Stockbridge, Georgia, United States Withdrawn -
Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic
Chicago, Illinois, United States Terminated -
Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States Terminated -
Global Scientific Innovations - Advanced Pain Care Clinic
Evansville, Indiana, United States Terminated -
Summit Research Institute
Fort Wayne, Indiana, United States Terminated -
Goodman Campbell Brain and Spine
Greenwood, Indiana, United States Withdrawn -
American Health Network of Indiana, LLC
Muncie, Indiana, United States Terminated -
Research Medical Center
Lenexa, Kansas, United States Terminated
+68 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Thanh Hoang, MS
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.