Paresthesia-Free Fast-Acting Subperception (FAST) Study
- Conditions
- Chronic Pain
- Interventions
- Device: Boston Scientific WaveWriter SCS System
- Registration Number
- NCT04618471
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 177
- Chronic pain (predominantly neuropathic) 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 when written informed consent is obtained
- 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
- Any pain-related diagnosis or medical/psychological condition or external factors 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WaveWriter Settings Boston Scientific WaveWriter SCS System -
- Primary Outcome Measures
Name Time Method Targeted Pain Responder Rate 3 months post-activation Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Vitamed Research
🇺🇸Palm Desert, California, United States
Denver Back Pain Specialists
🇺🇸Greenwood Village, Colorado, United States
South Lake Pain Institute, Inc
🇺🇸Clermont, Florida, United States
Willis-Knighton River Cities Clinical Research Center
🇺🇸Shreveport, Louisiana, United States
Goodman Campbell Brain and Spine
🇺🇸Carmel, Indiana, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Pacific Sports and Spine, LLC
🇺🇸Eugene, Oregon, United States
PCPMG Clinical Research Unit, LLC
🇺🇸Greenville, South Carolina, United States
Acute and Chronic Pain Therapies
🇺🇸Bellevue, Washington, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
The Orthopaedic Institute
🇺🇸Gainesville, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States