Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
- Conditions
- Chronic Pain
- Registration Number
- NCT02314000
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
- Detailed Description
To demonstrate sustained clinically significant pain relief in patients when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- Complaint of chronic pain of the trunk and/or limbs
- Willing and able to comply with all protocol-required procedures and assessments/evaluations; able to independently read and complete all questionnaires and assessments provided in English
- Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English
Key
- Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU)
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline 90 days post activation Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
MORE Foundation
🇺🇸Phoenix, Arizona, United States
Coastal Pain & Spinal Diagnostics
🇺🇸Carlsbad, California, United States
Kaiser Foundation Hospital - Redwood City
🇺🇸Redwood City, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Clearwater Pain Management
🇺🇸Clearwater, Florida, United States
Tallahassee Neurological Clinic, PA
🇺🇸Tallahassee, Florida, United States
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Orthopedic Research Foundation
🇺🇸Savannah, Georgia, United States
American Health Network of Indiana, LLC
🇺🇸Muncie, Indiana, United States
Forest Health Medical Center
🇺🇸Ypsilanti, Michigan, United States
Scroll for more (16 remaining)MORE Foundation🇺🇸Phoenix, Arizona, United States