Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
- Conditions
- Chronic Pain
- Interventions
- Device: Precision or Precision Spectra Spinal Cord Stimulator System
- 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
- Arm && Interventions
Group Intervention Description SCS starting with sub-perception amplitude Precision or Precision Spectra Spinal Cord Stimulator System Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS SCS starting with supra-perception Precision or Precision Spectra Spinal Cord Stimulator System Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
- 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)
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Orthopedic Research Foundation
🇺🇸Savannah, Georgia, United States
Jackson Anesthesia Pain Center, LLC
🇺🇸Jackson, Mississippi, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Kaiser Foundation Hospital - Redwood City
🇺🇸Redwood City, California, United States
Forest Health Medical Center
🇺🇸Ypsilanti, Michigan, United States
Clearwater Pain Management
🇺🇸Clearwater, Florida, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Coastal Pain & Spinal Diagnostics
🇺🇸Carlsbad, California, United States
KC Pain Centers
🇺🇸Lee's Summit, Missouri, United States
The Center for Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Pain & Rehabilitation
🇺🇸Pascagoula, Mississippi, United States
Vidant Roanoke - Chowan Hospital Pain Center
🇺🇸Ahoskie, North Carolina, United States
American Health Network of Indiana, LLC
🇺🇸Muncie, Indiana, United States
Mercy Medical Research Institute
🇺🇸Springfield, Missouri, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
TBI Clinical Research, L.L.C.
🇺🇸Plano, Texas, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
PCPMG Clinical Research Unit, LLC
🇺🇸Greenville, South Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Florence Neurosurgery and Spine
🇺🇸Florence, South Carolina, United States
MORE Foundation
🇺🇸Phoenix, Arizona, United States
University of Cincinnati Physicians Company
🇺🇸Cincinnati, Ohio, United States
Western Reserve Hospital
🇺🇸Cuyahoga Falls, Ohio, United States
Tallahassee Neurological Clinic, PA
🇺🇸Tallahassee, Florida, United States