Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
NCT ID: NCT01818297
Last Updated: 2017-09-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
137 participants
INTERVENTIONAL
2013-04-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment
Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant
PrimeAdvanced® neurostimulator system
Neurostimulator and associated components
Control
Control settings of Medtronic PrimeAdvanced® neurostimulator system implant
PrimeAdvanced® neurostimulator system
Neurostimulator and associated components
Interventions
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PrimeAdvanced® neurostimulator system
Neurostimulator and associated components
Eligibility Criteria
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Inclusion Criteria
* Had back surgery at least 6 months ago
* Have tried pain medications and physical therapy
* Read and understand written English or Spanish
* Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
* Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
* Have an expected lifespan greater than 12 months
Exclusion Criteria
* Currently enrolled in or plan to enroll in another drug and/or device study
* Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
* Have an active systemic infection or are immunocompromised
* Will be exposed to diathermy or anticipate needing a full-body MRI scan
* Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
* Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery
22 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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George Mandybur, MD
Role: PRINCIPAL_INVESTIGATOR
Mayfield Clinic, University of Cincinnati
Locations
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Valley Pain Consultants
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Coastal Pain Research
Carlsbad, California, United States
Pain Medicine Associates
Fountain Valley, California, United States
Florida Pain Institute
Merritt Island, Florida, United States
Advanced Medicine and Pain Management Research
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Willis Knighton River Cities Clinical Research Center
Shreveport, Louisiana, United States
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, United States
Columbia Interventional Pain Center, LLP
Columbia, Missouri, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Mayfield Clinic
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Summa Western Reserve Hospital
Cuyahoga Falls, Ohio, United States
DNA Advanced Pain Treatment Center
Greensburg, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Southern Spine Institute
Mt. Pleasant, South Carolina, United States
Austin Pain Associates
Cedar Park, Texas, United States
Space City Pain Specialists
Webster, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Wisconsin Health Center Surgery Center
Greenfield, Wisconsin, United States
Countries
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Other Identifiers
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G120146
Identifier Type: OTHER
Identifier Source: secondary_id
1666
Identifier Type: -
Identifier Source: org_study_id