Clinical trial NCT02314000: Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-10
Enrollment: 229
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline
timeFrame: 90 days post activation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MORE Foundation
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Pain & Spinal Diagnostics
state: California
city: Redwood City
country: United States
facility: Kaiser Foundation Hospital - Redwood City
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Clearwater
country: United States
facility: Clearwater Pain Management
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Savannah
country: United States
facility: Orthopedic Research Foundation
state: Georgia
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Anesthesia Pain Center, LLC
state: Mississippi
city: Pascagoula
country: United States
facility: Comprehensive Pain & Rehabilitation
state: Mississippi
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Ahoskie
country: United States
facility: Vidant Roanoke - Chowan Hospital Pain Center
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Western Reserve Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Florence
country: United States
facility: Florence Neurosurgery and Spine
state: South Carolina
city: Greenville
country: United States
facility: PCPMG Clinical Research Unit, LLC
state: South Carolina
city: Plano
country: United States
facility: TBI Clinical Research, L.L.C.
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Roshini Jain, M.S.
role: STUDY_DIRECTOR
References:
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.