Effectiveness of the Precision Spinal Cord Stimulator System at Sub-Perception Amplitude
NCT ID: NCT02314000
Last Updated: 2021-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
229 participants
INTERVENTIONAL
2014-12-31
2018-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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SCS starting with supra-perception
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
SCS starting with sub-perception amplitude
Precision or Precision Spectra Spinal Cord Stimulator System programmed at sub-perception followed by supra-perception SCS
Precision or Precision Spectra Spinal Cord Stimulator System
Interventions
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Precision or Precision Spectra Spinal Cord Stimulator System
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
22 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain, M.S.
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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MORE Foundation
Phoenix, Arizona, United States
Coastal Pain & Spinal Diagnostics
Carlsbad, California, United States
Kaiser Foundation Hospital - Redwood City
Redwood City, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Clearwater Pain Management
Clearwater, Florida, United States
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, United States
Shepherd Center
Atlanta, Georgia, United States
Orthopedic Research Foundation
Savannah, Georgia, United States
American Health Network of Indiana, LLC
Muncie, Indiana, United States
Forest Health Medical Center
Ypsilanti, Michigan, United States
Jackson Anesthesia Pain Center, LLC
Jackson, Mississippi, United States
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, United States
KC Pain Centers
Lee's Summit, Missouri, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Vidant Roanoke - Chowan Hospital Pain Center
Ahoskie, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Western Reserve Hospital
Cuyahoga Falls, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Florence Neurosurgery and Spine
Florence, South Carolina, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, United States
TBI Clinical Research, L.L.C.
Plano, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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90987574
Identifier Type: OTHER
Identifier Source: secondary_id
A4046
Identifier Type: -
Identifier Source: org_study_id
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