Evaluating long-term effectiveness of neurostimulation therapy for pain
A Global Prospective Observational Post-Market Study to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain
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 |
|---|---|
| Enrollment | 4800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 118 sites (Phoenix, Arizona and 117 other locations) |
| Trial ID | NCT01719055 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled to trial a commercially approved Boston Scientific neurostimulation system for pain.
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.
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 performed: Other studies have shown success with similar neurostimulation approaches, indicating a promising avenue for pain management.
Eligibility criteria
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 this trial is running
Phoenix, Arizona and 117 other locations
- 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)
- 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)
- 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)
- Neuroscience Associates of Northern Kentucky — Crestview Hills, Kentucky, United States (Withdrawn)
- Bux Pain Management — Danville, Kentucky, United States (Terminated)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Recruiting)
- Willis-Knighton River Cities Clinical Research Center — Shreveport, Louisiana, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Brookline, Massachusetts, United States (Terminated)
- Michigan Pain Specialists — Ann Arbor, Michigan, United States (Recruiting)
- Insight Institute of Neurosurgery & Neuroscience — Flint, Michigan, United States (Terminated)
- Forest Health Medical Center — Ypsilanti, Michigan, United States (Terminated)
- Jackson Anesthesia Pain Center, LLC — Jackson, Mississippi, United States (Terminated)
- Midwest Pain Center — Chesterfield, Missouri, United States (Terminated)
- Saint Louis Pain Consultants — Chesterfield, Missouri, United States (Terminated)
- KC Pain Centers — Lee's Summit, Missouri, United States (Terminated)
- Hope Research Institute — Las Vegas, Nevada, United States (Withdrawn)
- Albany Medical Center — Albany, New York, United States (Terminated)
- New York Presbyterian Hospital — New York, New York, United States (Terminated)
- University of Rochester — Rochester, New York, United States (Terminated)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Spine and Skeletal Pain Medicine — Utica, New York, United States (Terminated)
- Carolinas Research Institute, PLLC — Huntersville, North Carolina, United States (Terminated)
- Raleigh Neurology Associates, P.A. — Raleigh, North Carolina, United States (Terminated)
- The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States (Terminated)
- Case Western Reserve University — Cleveland, Ohio, United States (Completed)
- Ohio State University Medical Center — Columbus, Ohio, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.