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NCT02314000 Clinical Trial

Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Chronic Pain Clinical Trial

— WHISPER  

Official title:
WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02314000
Other study ID # A4046
Secondary ID 90987574
Status Completed
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date August 7, 2018

Study information
Verified date January 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 229
Est. completion date August 7, 2018
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Key Inclusion Criteria: 1. Complaint of chronic pain of the trunk and/or limbs 2. 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 3. Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English Key Exclusion Criteria: 1. Meets any contraindication in the Precision SCS system per locally applicable Directions for Use (DFU) 2. Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Precision or Precision Spectra Spinal Cord Stimulator System

Locations
Country Name City State
United States Vidant Roanoke - Chowan Hospital Pain Center Ahoskie North Carolina
United States Shepherd Center Atlanta Georgia
United States Coastal Pain & Spinal Diagnostics Carlsbad California
United States University of Cincinnati Physicians Company Cincinnati Ohio
United States Clearwater Pain Management Clearwater Florida
United States Cleveland Clinic Foundation Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Western Reserve Hospital Cuyahoga Falls Ohio
United States Geisinger Medical Center Danville Pennsylvania
United States Florence Neurosurgery and Spine Florence South Carolina
United States PCPMG Clinical Research Unit, LLC Greenville South Carolina
United States Jackson Anesthesia Pain Center, LLC Jackson Mississippi
United States KC Pain Centers Lee's Summit Missouri
United States American Health Network of Indiana, LLC Muncie Indiana
United States Comprehensive Pain & Rehabilitation Pascagoula Mississippi
United States MORE Foundation Phoenix Arizona
United States TBI Clinical Research, L.L.C. Plano Texas
United States Kaiser Foundation Hospital - Redwood City Redwood City California
United States University of California, Davis Medical Center Sacramento California
United States Orthopedic Research Foundation Savannah Georgia
United States Swedish Medical Center Seattle Washington
United States Mercy Medical Research Institute Springfield Missouri
United States Tallahassee Neurological Clinic, PA Tallahassee Florida
United States University of Toledo Medical Center Toledo Ohio
United States The Center for Clinical Research, LLC Winston-Salem North Carolina
United States Forest Health Medical Center Ypsilanti Michigan

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline 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 90 days post activation
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