Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
NCT ID: NCT03345472
Last Updated: 2020-11-03
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
175 participants
INTERVENTIONAL
2017-11-30
2019-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Interventions
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Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of low back and leg pain
* Moderate to crippled disability due to pain
* Stable pain medications for back and leg pain for at least 28 days prior to enrollment
* Willing and able to not increase pain medications through the 3-Month visit
Exclusion Criteria
* Current diagnosis of moderate to severe central lumbar spinal stenosis
* Major psychiatric comorbidity or other progressive diseases
* Serious drug-related behavioral issues
* Pregnant or planning on becoming pregnant
* Unable to achieve supine position
18 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Principal Investigators
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Vectors Post Market Clinical Research Study Team
Role: STUDY_DIRECTOR
Medtronic Restorative Therapies, Pain Therapy
Locations
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Pain Consultants of San Diego
La Mesa, California, United States
Restore Orthopedics and Spine Center
Orange, California, United States
Center for Interventional Pain and Spine
Wilmington, Delaware, United States
Pain Care
Stockbridge, Georgia, United States
National Spine and Pain
Oxon Hill, Maryland, United States
Michigan Pain Consultants
Wyoming, Michigan, United States
Comprehensive and Interventional Pain Management
Henderson, Nevada, United States
The Pain Management Center
Voorhees Township, New Jersey, United States
University of Rochester Neurosurgery Partners Pain Management
Rochester, New York, United States
Carolinas Pain Center
Huntersville, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lehigh Valley Healthcare Network
Allentown, Pennsylvania, United States
Saint Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, United States
Lowcountry Orthopaedics/Coastal Carolina Research Center
Charleston, South Carolina, United States
Carolina Center for Advanced Management of Pain
Spartanburg, South Carolina, United States
Precision Spine Care
Tyler, Texas, United States
Carilion Clinic Roanoke Memorial Hospital
Roanoke, Virginia, United States
Northwest Pain Care
Spokane, Washington, United States
Countries
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References
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Hatheway JA, Mangal V, Fishman MA, Kim P, Shah B, Vogel R, Galan V, Severyn S, Weaver TE, Provenzano DA, Chang E, Verdolin MH, Howes G, Villarreal A, Falowski S, Hendrickson K, Stromberg K, Davies L, Johanek L, Kelly MT. Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Neuromodulation. 2021 Apr;24(3):556-565. doi: 10.1111/ner.13324. Epub 2020 Dec 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT17053
Identifier Type: -
Identifier Source: org_study_id