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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Pain
Intervention Device: Precision or Precision Spectra Spinal Cord Stimulator System
Enrollment 229
Recruitment Details Enrolled subjects underwent study eligibility to determine if they can continue in the study. Following completion of study eligibility, subjects were randomized to the cross-over phase.
Pre-assignment Details  
Arm/Group Title SCS Starting With Supra-perception Amplitude SCS Starting With Sub-perception Amplitude
Hide Arm/Group Description

Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with supra-perception followed by sub‐perception amplitude.

Precision or Precision Spectra Spinal Cord Stimulator System

Precision or Precision Spectra Spinal Cord Stimulator System programmed starting with sub-perception and followed by supra‐perception amplitude.

Precision or Precision Spectra Spinal Cord Stimulator System

Period Title: Overall Study
Started 75 65
Completed 62 57
Not Completed 13 8
Arm/Group Title SCS Starting at Supra-perception Amplitude SCS Starting at Sub-perception Amplitude Total
Hide Arm/Group Description

Precision or Precision Spectra Spinal Cord Stimulator System programmed starting at supra-perception and followed by sub‐perception amplitude.

Precision or Precision Spectra Spinal Cord Stimulator System

Precision or Precision Spectra Spinal Cord Stimulator System starting at sub-perception and followed by supra‐perception amplitude.

Precision or Precision Spectra Spinal Cord Stimulator System

Total of all reporting groups
Overall Number of Baseline Participants 75 65 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 65 participants 140 participants
60.7  (11.9) 58.8  (10.7) 59.8  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 65 participants 140 participants
Female
44
  58.7%
39
  60.0%
83
  59.3%
Male
31
  41.3%
26
  40.0%
57
  40.7%
1.Primary Outcome
Title Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants.
Arm/Group Title SCS With Supra-perception Amplitude SCS With Sub-perception Amplitude
Hide Arm/Group Description:

Precision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception amplitude

Precision or Precision Spectra Spinal Cord Stimulator System

Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception amplitude

Precision or Precision Spectra Spinal Cord Stimulator System

Overall Number of Participants Analyzed 119 118
Measure Type: Count of Participants
Unit of Measure: Participants
32
  26.9%
41
  34.7%
Time Frame Adverse events up to end of cross over period - approximately upto 180 days after randomization
Adverse Event Reporting Description Adverse events up to end of cross over period - approximately upto 180 days after randomization
 
Arm/Group Title All Study Patients Through End of Randomized Phase SCS With Supra Perception Amplitude SCS With Subperception Amplitude
Hide Arm/Group Description All adverse events reported through end of randomized phase All adverse events during SCS with supra perception amplitude All adverse events during SCS with supra perception amplitude
All-Cause Mortality
All Study Patients Through End of Randomized Phase SCS With Supra Perception Amplitude SCS With Subperception Amplitude
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)      0/140 (0.00%)      0/140 (0.00%)    
Hide Serious Adverse Events
All Study Patients Through End of Randomized Phase SCS With Supra Perception Amplitude SCS With Subperception Amplitude
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/140 (5.00%)      3/140 (2.14%)      4/140 (2.86%)    
Gastrointestinal disorders       
Diverticular Perforation  1  1/140 (0.71%)  1 0/140 (0.00%)  0 1/140 (0.71%)  1
Enterocolitis Heamorrhagic  1  1/140 (0.71%)  1 0/140 (0.00%)  0 1/140 (0.71%)  1
Infections and infestations       
Gastroenteritis  1  1/140 (0.71%)  1 1/140 (0.71%)  1 0/140 (0.00%)  0
Pneumonia  1  2/140 (1.43%)  2 1/140 (0.71%)  1 1/140 (0.71%)  1
Cystitis  1  1/140 (0.71%)  1 0/140 (0.00%)  0 1/140 (0.71%)  1
Post Procedure Infection  1  1/140 (0.71%)  1 1/140 (0.71%)  1 0/140 (0.00%)  0
Renal and urinary disorders       
Renal Failure  1  1/140 (0.71%)  1 1/140 (0.71%)  1 0/140 (0.00%)  0
1
Term from vocabulary, MedDrRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Patients Through End of Randomized Phase SCS With Supra Perception Amplitude SCS With Subperception Amplitude
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/140 (0.00%)      0/140 (0.00%)      0/140 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Clinical study agreement that restricts PI until official study manuscript is available.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roshini Jain, Director of Clinical Sciences
Organization: Boston Scientific
Phone: 6619494355
EMail: roshini.jain@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02314000    
Other Study ID Numbers: A4046
90987574 ( Other Identifier: Boston Scientific (study protocol number) )
First Submitted: December 8, 2014
First Posted: December 10, 2014
Results First Submitted: February 16, 2018
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019