Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
WHISPER
WHISPER - A Randomized Controlled Study to Evaluate the Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
2 other identifiers
interventional
229
1 country
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Dec 2014
Longer than P75 for not_applicable chronic-pain
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 8, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2018
CompletedResults Posted
Study results publicly available
April 12, 2019
CompletedFebruary 11, 2021
January 1, 2021
2 years
December 8, 2014
February 16, 2018
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
90 days post activation
Study Arms (2)
SCS starting with supra-perception
ACTIVE COMPARATORPrecision or Precision Spectra Spinal Cord Stimulator System programmed at supra-perception followed by sub-perception SCS
SCS starting with sub-perception amplitude
EXPERIMENTALPrecision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
MORE Foundation
Phoenix, Arizona, 85023, United States
Coastal Pain & Spinal Diagnostics
Carlsbad, California, 92009, United States
Kaiser Foundation Hospital - Redwood City
Redwood City, California, 94063, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Clearwater Pain Management
Clearwater, Florida, 33756, United States
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, 32308, United States
Shepherd Center
Atlanta, Georgia, 30309, United States
Orthopedic Research Foundation
Savannah, Georgia, 31405, United States
American Health Network of Indiana, LLC
Muncie, Indiana, 47304, United States
Forest Health Medical Center
Ypsilanti, Michigan, 48198, United States
Jackson Anesthesia Pain Center, LLC
Jackson, Mississippi, 39202, United States
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, 39581, United States
KC Pain Centers
Lee's Summit, Missouri, 64086, United States
Mercy Medical Research Institute
Springfield, Missouri, 65804, United States
Vidant Roanoke - Chowan Hospital Pain Center
Ahoskie, North Carolina, 27910, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Western Reserve Hospital
Cuyahoga Falls, Ohio, 44223, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Florence Neurosurgery and Spine
Florence, South Carolina, 29506, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29621, United States
TBI Clinical Research, L.L.C.
Plano, Texas, 75093, United States
Swedish Medical Center
Seattle, Washington, 98124, United States
Related Publications (1)
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.
PMID: 31265205DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roshini Jain, Director of Clinical Sciences
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Roshini Jain, M.S.
Boston Scientific Neuromodulation Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2014
First Posted
December 10, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2016
Study Completion
August 7, 2018
Last Updated
February 11, 2021
Results First Posted
April 12, 2019
Record last verified: 2021-01