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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision or Precision Spectra Spinal Cord Stimulator System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MORE Foundation
  • Coastal Pain & Spinal Diagnostics
  • Kaiser Foundation Hospital - Redwood City
  • University of California, Davis Medical Center
  • Clearwater Pain Management
  • Tallahassee Neurological Clinic, PA
  • Shepherd Center
  • Orthopedic Research Foundation
  • American Health Network of Indiana, LLC
  • Forest Health Medical Center
  • Jackson Anesthesia Pain Center, LLC
  • Comprehensive Pain & Rehabilitation
  • KC Pain Centers
  • Mercy Medical Research Institute
  • Vidant Roanoke - Chowan Hospital Pain Center
  • The Center for Clinical Research, LLC
  • University of Cincinnati Physicians Company
  • University Hospitals of Cleveland
  • Cleveland Clinic Foundation
  • Western Reserve Hospital
  • University of Toledo Medical Center
  • Geisinger Medical Center
  • Florence Neurosurgery and Spine
  • PCPMG Clinical Research Unit, LLC
  • TBI Clinical Research, L.L.C.
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SCS starting with supra-perception

SCS starting with sub-perception amplitude

Arm Description

Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS

Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 8, 2014
Last Updated
January 25, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02314000
Brief Title
Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Acronym
WHISPER
Official Title
WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCS starting with supra-perception
Arm Type
Active Comparator
Arm Description
Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
Arm Title
SCS starting with sub-perception amplitude
Arm Type
Experimental
Arm Description
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
Intervention Type
Device
Intervention Name(s)
Precision or Precision Spectra Spinal Cord Stimulator System
Primary Outcome Measure Information:
Title
Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Description
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
Time Frame
90 days post activation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain, M.S.
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
MORE Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Coastal Pain & Spinal Diagnostics
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Kaiser Foundation Hospital - Redwood City
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Clearwater Pain Management
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Tallahassee Neurological Clinic, PA
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Orthopedic Research Foundation
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Facility Name
Jackson Anesthesia Pain Center, LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Comprehensive Pain & Rehabilitation
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
KC Pain Centers
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Vidant Roanoke - Chowan Hospital Pain Center
City
Ahoskie
State/Province
North Carolina
ZIP/Postal Code
27910
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Western Reserve Hospital
City
Cuyahoga Falls
State/Province
Ohio
ZIP/Postal Code
44223
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Florence Neurosurgery and Spine
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
TBI Clinical Research, L.L.C.
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31265205
Citation
North J, Loudermilk E, Lee A, Sachdeva H, Kaiafas D, Washabaugh E, Sheth S, Scowcroft J, Mekhail N, Lampert B, Yearwood T, Shaw E, Atallah J, McLeod C, Han J, Yu C, Sedrak M, Lucas R, Trobridge A, Hegarty J, Miller N, Chen L, Jain R. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at </=1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108. doi: 10.1111/ner.13015. Epub 2019 Jul 2.
Results Reference
derived

Learn more about this trial

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

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