Fast-Acting Subperception Study (FAST)
Not Applicable
Terminated
- Conditions
- Chronic Pain
- Interventions
- Device: Boston Scientific Spectra WaveWriter SCS System
- Registration Number
- NCT04231409
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Study to Demonstrate the Value of Fast-Acting Subperception (FAST) using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
- Chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- 22 years of age or older at time of enrollment
- Able to independently read and complete all questionnaires and assessments provided in English
- Signed a valid, IRB-approved informed consent form (ICF) provided in English
Key
Exclusion Criteria
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WaveWriter Settings Boston Scientific Spectra WaveWriter SCS System WaveWriter Programming Conventional Settings Boston Scientific Spectra WaveWriter SCS System Conventional Programming
- Primary Outcome Measures
Name Time Method Overall Pain Responder Rate 3 months post-randomization Proportion of subjects with 50% or greater reduction from Baseline Visit in average overall pain intensity at 3 months post-randomization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Center for Pain and Supportive Care
🇺🇸Phoenix, Arizona, United States
Willis-Knighton River Cities Clinical Research Center
🇺🇸Shreveport, Louisiana, United States
The Center for Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Pacific Sports and Spine, LLC
🇺🇸Eugene, Oregon, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States
Center for Pain and Supportive Care🇺🇸Phoenix, Arizona, United States