Study Results
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View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2020-11-05
2022-08-25
Brief Summary
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Detailed Description
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* Visual Analog Scale
* Programming Parameters
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spinal Cord Stimulation
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Interventions
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Spinal Cord Stimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide signed and dated informed consent
* Capable of comprehending and consenting in English
* Candidate per labeling for an SCS system as an aid in the management of chronic, intractable pain of the trunk and/or limbs
* Has moderate to severe back and leg pain
* Stable pain medications for back and leg pain for at least 28 days prior to enrollment
* Willing and able to comply with all study procedures and visits
* Willing and able to not increase their pain medications through the 3-Month visit
* Able to differentiate between pain associated with the indication for SCS implant and other types of pain
Exclusion Criteria
* Expected to be inaccessible for follow-up
* Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication
* Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
* If female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
* Has untreated major psychiatric comorbidity
* Serious drug-related behavioral issues
* Unable to achieve supine or prone position
* Classified as vulnerable or requires a legally authorized representative (LAR)
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Restorative Therapies Group Restorative Therapies Group
Role: STUDY_DIRECTOR
Medtronic
Locations
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IPM Medical Group
Walnut Creek, California, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
Drez One LLC
Somerset, Kentucky, United States
Carolinas Pain Center
Huntersville, North Carolina, United States
Novant Health
Winston-Salem, North Carolina, United States
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, United States
The Woodlands Pain Institute
Conroe, Texas, United States
The Burkhart Research Institute for Orthopaedics
San Antonio, Texas, United States
Sprintz Center for Pain
Shenandoah, Texas, United States
Precision Spine Care
Tyler, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT20042
Identifier Type: -
Identifier Source: org_study_id
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