WHISPER: Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02314000
Collaborator
(none)
229
26
2
44.2
8.8
0.2
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
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
:
Dec 1, 2014
Actual Primary Completion Date
:
Dec 1, 2016
Actual Study Completion Date
:
Aug 7, 2018
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
22 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MORE Foundation | Phoenix | Arizona | United States | 85023 |
| 2 | Coastal Pain & Spinal Diagnostics | Carlsbad | California | United States | 92009 |
| 3 | Kaiser Foundation Hospital - Redwood City | Redwood City | California | United States | 94063 |
| 4 | University of California, Davis Medical Center | Sacramento | California | United States | 95817 |
| 5 | Clearwater Pain Management | Clearwater | Florida | United States | 33756 |
| 6 | Tallahassee Neurological Clinic, PA | Tallahassee | Florida | United States | 32308 |
| 7 | Shepherd Center | Atlanta | Georgia | United States | 30309 |
| 8 | Orthopedic Research Foundation | Savannah | Georgia | United States | 31405 |
| 9 | American Health Network of Indiana, LLC | Muncie | Indiana | United States | 47304 |
| 10 | Forest Health Medical Center | Ypsilanti | Michigan | United States | 48198 |
| 11 | Jackson Anesthesia Pain Center, LLC | Jackson | Mississippi | United States | 39202 |
| 12 | Comprehensive Pain & Rehabilitation | Pascagoula | Mississippi | United States | 39581 |
| 13 | KC Pain Centers | Lee's Summit | Missouri | United States | 64086 |
| 14 | Mercy Medical Research Institute | Springfield | Missouri | United States | 65804 |
| 15 | Vidant Roanoke - Chowan Hospital Pain Center | Ahoskie | North Carolina | United States | 27910 |
| 16 | The Center for Clinical Research, LLC | Winston-Salem | North Carolina | United States | 27103 |
| 17 | University of Cincinnati Physicians Company | Cincinnati | Ohio | United States | 45219 |
| 18 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
| 19 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 20 | Western Reserve Hospital | Cuyahoga Falls | Ohio | United States | 44223 |
| 21 | University of Toledo Medical Center | Toledo | Ohio | United States | 43614 |
| 22 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 23 | Florence Neurosurgery and Spine | Florence | South Carolina | United States | 29506 |
| 24 | PCPMG Clinical Research Unit, LLC | Greenville | South Carolina | United States | 29621 |
| 25 | TBI Clinical Research, L.L.C. | Plano | Texas | United States | 75093 |
| 26 | Swedish Medical Center | Seattle | Washington | United States | 98124 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Roshini Jain, M.S., Boston Scientific Neuromodulation Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02314000
Other Study ID Numbers:
- A4046
- 90987574
First Posted:
Dec 10, 2014
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2021
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail |
| Arm/Group Title | SCS Starting With Supra-perception Amplitude | SCS Starting With Sub-perception Amplitude |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | SCS Starting at Supra-perception Amplitude | SCS Starting at Sub-perception Amplitude | Total |
|---|---|---|---|
| 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 Participants | 75 | 65 | 140 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.7
(11.9)
|
58.8
(10.7)
|
59.8
(11.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
44
58.7%
|
39
60%
|
83
59.3%
|
| Male |
31
41.3%
|
26
40%
|
57
40.7%
|
Outcome Measures
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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 |
| Measure Participants | 119 | 118 |
| Count of Participants [Participants] |
32
42.7%
|
41
63.1%
|
Adverse Events
| 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 | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/140 (0%) | 0/140 (0%) | 0/140 (0%) | |||
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%) | 3/140 (2.1%) | 4/140 (2.9%) | |||
| Gastrointestinal disorders | ||||||
| Diverticular Perforation | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 | 1/140 (0.7%) | 1 |
| Enterocolitis Heamorrhagic | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 | 1/140 (0.7%) | 1 |
| Infections and infestations | ||||||
| Gastroenteritis | 1/140 (0.7%) | 1 | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 |
| Pneumonia | 2/140 (1.4%) | 2 | 1/140 (0.7%) | 1 | 1/140 (0.7%) | 1 |
| Cystitis | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 | 1/140 (0.7%) | 1 |
| Post Procedure Infection | 1/140 (0.7%) | 1 | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Renal Failure | 1/140 (0.7%) | 1 | 1/140 (0.7%) | 1 | 0/140 (0%) | 0 |
Other (Not Including 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 | 0/140 (0%) | 0/140 (0%) | 0/140 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Clinical study agreement that restricts PI until official study manuscript is available.
Results Point of Contact
| Name/Title | Roshini Jain, Director of Clinical Sciences |
|---|---|
| Organization | Boston Scientific |
| Phone | 6619494355 |
| roshini.jain@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02314000
Other Study ID Numbers:
- A4046
- 90987574
First Posted:
Dec 10, 2014
Last Update Posted:
Feb 11, 2021
Last Verified:
Jan 1, 2021