- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02314000
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude (WHISPER)
January 25, 2021 updated by: Boston Scientific Corporation
WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
229
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- MoRe Foundation
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California
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Carlsbad, California, United States, 92009
- Coastal Pain & Spinal Diagnostics
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Redwood City, California, United States, 94063
- Kaiser Foundation Hospital - Redwood City
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Sacramento, California, United States, 95817
- University of California, Davis Medical Center
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Florida
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Clearwater, Florida, United States, 33756
- Clearwater Pain Management
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Tallahassee, Florida, United States, 32308
- Tallahassee Neurological Clinic, PA
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Georgia
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Atlanta, Georgia, United States, 30309
- Shepherd Center
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Savannah, Georgia, United States, 31405
- Orthopedic Research Foundation
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-
Indiana
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Muncie, Indiana, United States, 47304
- American Health Network of Indiana, LLC
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Michigan
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Ypsilanti, Michigan, United States, 48198
- Forest Health Medical Center
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Mississippi
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Jackson, Mississippi, United States, 39202
- Jackson Anesthesia Pain Center, LLC
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Pascagoula, Mississippi, United States, 39581
- Comprehensive Pain & Rehabilitation
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Missouri
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Lee's Summit, Missouri, United States, 64086
- KC Pain Centers
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Springfield, Missouri, United States, 65804
- Mercy Medical Research Institute
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North Carolina
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Ahoskie, North Carolina, United States, 27910
- Vidant Roanoke - Chowan Hospital Pain Center
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research, LLC
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati Physicians Company
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Cuyahoga Falls, Ohio, United States, 44223
- Western Reserve Hospital
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Toledo, Ohio, United States, 43614
- University of Toledo Medical Center
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Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
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South Carolina
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Florence, South Carolina, United States, 29506
- Florence Neurosurgery and Spine
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Greenville, South Carolina, United States, 29621
- PCPMG Clinical Research Unit, LLC
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Texas
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Plano, Texas, United States, 75093
- TBI Clinical Research, L.L.C.
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Washington
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Seattle, Washington, United States, 98124
- Swedish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SCS starting with supra-perception
Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
|
|
Experimental: SCS starting with sub-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Time Frame: 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
|
90 days post activation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Roshini Jain, M.S., Boston Scientific Neuromodulation Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
August 7, 2018
Study Registration Dates
First Submitted
December 8, 2014
First Submitted That Met QC Criteria
December 8, 2014
First Posted (Estimate)
December 10, 2014
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4046
- 90987574 (Other Identifier: Boston Scientific (study protocol number))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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