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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COMPLETED
NA
64 participants
INTERVENTIONAL
2015-07-31
2016-08-31
Brief Summary
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Detailed Description
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The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open label treatment
Spinal Cord Stimulation (SCS)
Spinal Cord Stimulation (SCS)
SCS programming options
Interventions
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Spinal Cord Stimulation (SCS)
SCS programming options
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide a signed and dated informed consent
* At least 18 years old at the time of informed consent
* Willing and able to attend visits and comply with the study protocol
* Capable of using the patient programmer and recharging the neurostimulator
* Willing to not increase pain medications from baseline through the 3-Month Visit
Exclusion Criteria
* Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol.
* Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
* Implanted with a cardiac device (e.g., pacemaker, defibrillator)
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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OPTIONS Clinical Research Study Team
Role: STUDY_DIRECTOR
Medtronic Implantable Therapies
Locations
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Valley Pain Consultants-North Scottsdale
Scottsdale, Arizona, United States
Synovation Medical Group
Chula Vista, California, United States
Center for Interventional Pain Spine
Wilmington, Delaware, United States
Pain Care LLC
Stockbridge, Georgia, United States
Millennium Pain Center
Bloomington, Illinois, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
St. Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, United States
Precision Spine Care
Tyler, Texas, United States
Swedish Pain Services
Seattle, Washington, United States
Northwest Pain Care
Spokane, Washington, United States
Countries
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Other Identifiers
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1675
Identifier Type: -
Identifier Source: org_study_id