SUNBURST (Success Using Neuromodulation With BURST) Study
NCT ID: NCT02011893
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
173 participants
INTERVENTIONAL
2013-12-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Burst Stimulation
Burst Stimulation using the Prodigy system
Burst Stimulation
Prodigy Neurostimulation System with associated components
Tonic Stimulation
Tonic Stimulation using the Prodigy system
Tonic Stimulation
Prodigy Neurostimulation System with associated components
Interventions
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Tonic Stimulation
Prodigy Neurostimulation System with associated components
Burst Stimulation
Prodigy Neurostimulation System with associated components
Eligibility Criteria
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Inclusion Criteria
* Subject has chronic intractable pain of the trunk and/or limbs
* Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 7 day pain diary
* Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
* Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Subject agrees not to add or increase pain-related medication from activation through the 24 week follow-up visit
Exclusion Criteria
* Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation system
* Subject's overall Beck Depression Inventory II Score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit
* Subject has an infusion pump or any implantable neurostimulator device
* Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment
* Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (MRI) evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
* Subject has an existing medical condition that is likely to require the use of diathermy in the future
* Subject's pain originates from peripheral vascular disease
* Subject is immunocompromised
* Subject has documented history of allergic response to titanium or silicone
* Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
* Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)
22 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Deer, MD
Role: STUDY_CHAIR
The Center for Pain Relief
Locations
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Newport Beach Headache and Pain
Mission Viejo, California, United States
Napa Biomedical Services
Napa, California, United States
Eisenhower Desert Orthopedic Center
Rancho Mirage, California, United States
IPM Medical Group
Walnut Creek, California, United States
Goodman Campbell Brain and Spine
Indianapolis, Indiana, United States
Bronson Neuroscience Center
Kalamazoo, Michigan, United States
The Neuroscience Center
Biloxi, Mississippi, United States
Jackson Pain Center
Jackson, Mississippi, United States
Comprehensive Pain & Rehabilitation
Pascagoula, Mississippi, United States
Midwest Neurosurgery Associates
Kansas City, Missouri, United States
The Montana Center for Wellness & Pain Management
Kalispell, Montana, United States
Albany Medical Center
Albany, New York, United States
New York Spine & Wellness Center
North Syracuse, New York, United States
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, United States
NeuroSpine Institute
Eugene, Oregon, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Clinical Trials of South Carolina
North Charleston, South Carolina, United States
Houston Pain Centers
Houston, Texas, United States
Utah Spine Care
Ogden, Utah, United States
The Center for Pain Relief
Charleston, West Virginia, United States
Countries
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References
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Slavin KV, North RB, Deer TR, Staats P, Davis K, Diaz R. Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.
Other Identifiers
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C-12-07
Identifier Type: -
Identifier Source: org_study_id
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