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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314000
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Precision or Precision Spectra Spinal Cord Stimulator System Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Actual Study Start Date : December 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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
Device: Precision or Precision Spectra Spinal Cord Stimulator System
Experimental: SCS starting with sub-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
Device: Precision or Precision Spectra Spinal Cord Stimulator System



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314000


Locations
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United States, California
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, United States, 91355
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain, M.S. Boston Scientific Neuromodulation Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02314000    
Other Study ID Numbers: A4046
90987574 ( Other Identifier: Boston Scientific (study protocol number) )
First Posted: December 10, 2014    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms