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



Status:Active, not recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:22 - Any
Updated:1/27/2018
Start Date:December 2014
End Date:December 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

To demonstrate sustained clinically significant pain relief in patients when using the Boston
Scientific Precision Spinal Cord Stimulator (SCS) System at sub‐perception amplitude

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, 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
We found this trial at
1
site
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California 91355
Phone: 855-213-9890
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Valencia, CA
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