Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
1 other identifier
interventional
175
1 country
20
Brief Summary
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Nov 2017
Typical duration for not_applicable chronic-pain
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 21, 2019
CompletedResults Posted
Study results publicly available
March 20, 2020
CompletedNovember 3, 2020
October 1, 2020
1.2 years
November 14, 2017
February 3, 2020
October 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS). The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain. The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study.
Baseline to 3 months
Secondary Outcomes (3)
Overall Pain Efficacy Responder Rate
Baseline to 3 months
Low Back Pain Efficacy Responder Rate
Baseline to 3 months
Leg Pain Efficacy Responder Rate
Baseline to 3 months
Study Arms (1)
Treated
EXPERIMENTALEnrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Interventions
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Eligibility Criteria
You may qualify if:
- Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- 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
You may not qualify if:
- Previously trialed or implanted with stimulator or intrathecal drug delivery system
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (20)
Pain Consultants of San Diego
La Mesa, California, 91942-8901, United States
Restore Orthopedics and Spine Center
Orange, California, 92868, United States
Center for Interventional Pain and Spine
Wilmington, Delaware, 19803, United States
Pain Care
Stockbridge, Georgia, 30281-5023, United States
National Spine and Pain
Oxon Hill, Maryland, 20745, United States
Michigan Pain Consultants
Wyoming, Michigan, 49519, United States
Comprehensive and Interventional Pain Management
Henderson, Nevada, 89052, United States
The Pain Management Center
Voorhees Township, New Jersey, 08043-3512, United States
University of Rochester Neurosurgery Partners Pain Management
Rochester, New York, 14618, United States
Carolinas Pain Center
Huntersville, North Carolina, 28078, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Lehigh Valley Healthcare Network
Allentown, Pennsylvania, 18103, United States
Saint Luke's Neurosurgical Associates
Bethlehem, Pennsylvania, 18015, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15134, United States
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, 19053, United States
Lowcountry Orthopaedics/Coastal Carolina Research Center
Charleston, South Carolina, 29406, United States
Carolina Center for Advanced Management of Pain
Spartanburg, South Carolina, 29303, United States
Precision Spine Care
Tyler, Texas, 75701, United States
Carilion Clinic Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Northwest Pain Care
Spokane, Washington, 99201, United States
Related Publications (1)
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.
PMID: 33296127DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stacie Hallaway/Senior Clinical Research Specialist
- Organization
- Medtronic Restorative Therapies Group, Spinal Cord Stimulation
Study Officials
- STUDY DIRECTOR
Vectors Post Market Clinical Research Study Team
Medtronic Restorative Therapies, Pain Therapy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2017
First Posted
November 17, 2017
Study Start
November 30, 2017
Primary Completion
February 4, 2019
Study Completion
October 21, 2019
Last Updated
November 3, 2020
Results First Posted
March 20, 2020
Record last verified: 2020-10