Boston Scientific WaveWriter SCS System: WaveWriter SCS Programming
Study 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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
* 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 Exclusion Criteria:
* 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
Primary outcome measure(s)
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
Trial sites (13)
Facility
City
Region
Status
Vitamed Research
Palm Desert
California
Denver Back Pain Specialists
Greenwood Village
Colorado
Orlando Health Neuroscience Institute
Clermont
Florida
The Orthopaedic Institute
Gainesville
Florida
University of Chicago Hospital
Chicago
Illinois
Goodman Campbell Brain and Spine
Carmel
Indiana
Willis-Knighton River Cities Clinical Research Center
Shreveport
Louisiana
Montefiore Medical Center
The Bronx
New York
The Center for Clinical Research
Winston-Salem
North Carolina
Cleveland Clinic Foundation
Cleveland
Ohio
Pacific Sports and Spine, LLC
Eugene
Oregon
PCPMG Clinical Research Unit, LLC
Greenville
South Carolina
Acute and Chronic Pain Therapies
Bellevue
Washington
More Boston Scientific Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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