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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • More Foundation
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Pain & Spinal Diagnostics
      • Redwood City, California, United States, 94063
        • Kaiser Foundation Hospital - Redwood City
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Clearwater Pain Management
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Neurological Clinic, PA
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
      • Savannah, Georgia, United States, 31405
        • Orthopedic Research Foundation
    • Indiana
      • Muncie, Indiana, United States, 47304
        • American Health Network of Indiana, LLC
    • Michigan
      • Ypsilanti, Michigan, United States, 48198
        • Forest Health Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Anesthesia Pain Center, LLC
      • Pascagoula, Mississippi, United States, 39581
        • Comprehensive Pain & Rehabilitation
    • Missouri
      • Lee's Summit, Missouri, United States, 64086
        • KC Pain Centers
      • Springfield, Missouri, United States, 65804
        • Mercy Medical Research Institute
    • North Carolina
      • Ahoskie, North Carolina, United States, 27910
        • Vidant Roanoke - Chowan Hospital Pain Center
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Physicians Company
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Cuyahoga Falls, Ohio, United States, 44223
        • Western Reserve Hospital
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • Florence Neurosurgery and Spine
      • Greenville, South Carolina, United States, 29621
        • PCPMG Clinical Research Unit, LLC
    • Texas
      • Plano, Texas, United States, 75093
        • TBI Clinical Research, L.L.C.
    • Washington
      • Seattle, Washington, United States, 98124
        • Swedish Medical Center

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:

  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 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
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

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

Boston Scientific Corporation

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.

General Publications

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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