Clinical trial Recruiting at 28 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment4800 (estimated)
SponsorBoston Scientific Corporation
Industry-sponsored
Locations118 sites (Phoenix, Arizona and 117 other locations)
StatusRecruiting
StartedNovember 19, 2012
Main results expectedMay 2035
Study endsMay 2035
Registry record updatedOctober 13, 2026
Trial IDNCT01719055 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.