Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation



Status:Active, not recruiting
Conditions:Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:November 30, 2017
End Date:October 31, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
20
sites
Michigan Pain Consultants
Wyoming, Michigan 49519
Principal Investigator: Daniel Mankoff, M.D.
Phone: 616-940-5008
?
mi
from
Wyoming, MI
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Lehigh Valley Healthcare Network
Allentown, Pennsylvania 18103
Principal Investigator: Bruce Nicholson, MD
Phone: 610-402-8447
?
mi
from
Allentown, PA
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Saint Luke's Neurosurgical Associates
Bethlehem, Pennsylvania 18015
Principal Investigator: Steven Falowski, M.D.
Phone: 484-526-7825
?
mi
from
Bethlehem, PA
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Lowcountry Orthopaedics/Coastal Carolina Research Center
2880 Tricom Street
Charleston, South Carolina 29406
Principal Investigator: Christopher Merrell, M.D.
Phone: 843-856-3784
?
mi
from
Charleston, SC
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Steven Severyn, M.D.
Phone: 614-293-3559
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
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Comprehensive and Interventional Pain Management
Henderson, Nevada 89052
Principal Investigator: Rainer Vogel, M.D.
Phone: 702-990-4530
?
mi
from
Henderson, NV
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Carolinas Pain Center
9735 Kincey Avenue
Huntersville, North Carolina 28078
Principal Investigator: Binit Shah, M.D.
Phone: 704-500-2332
?
mi
from
Huntersville, NC
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Pain Consultants of San Diego
7051 Alvarado Road
La Mesa, California 91942
Principal Investigator: Michael Verdolin, M.D.
Phone: 619-625-1144
?
mi
from
La Mesa, CA
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Restore Orthopedics and Spine Center
Orange, California 92868
Principal Investigator: Eric Y Chang, MD
Phone: 714-979-4101
?
mi
from
Orange, CA
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National Spine and Pain
Oxon Hill, Maryland 20745
?
mi
from
Oxon Hill, MD
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Carilion Clinic Roanoke Memorial Hospital
Roanoke, Virginia 24014
Principal Investigator: Greg Howes, M.D.
Phone: 540-320-9139
?
mi
from
Roanoke, VA
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University of Rochester Neurosurgery Partners in Pain Management
Rochester, New York 14618
Principal Investigator: Armando Villarreal, M.D.
Phone: 585-276-8489
?
mi
from
Rochester, NY
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Pain Diagnostics and Interventional Care
301 Ohio River Boulevard
Sewickley, Pennsylvania 15143
Principal Investigator: David Provenzano, M.D.
Phone: 412-221-7640
?
mi
from
Sewickley, PA
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Carolina Center for Advanced Management of Pain
Spartanburg, South Carolina
Principal Investigator: Kelby Hutcheson, MD
Phone: 864-316-2587
?
mi
from
Spartanburg, SC
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Northwest Pain Care
Spokane, Washington 99201
Principal Investigator: John Hatheway, M.D.
Phone: 509-435-2077
?
mi
from
Spokane, WA
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Pain Care LLC
Stockbridge, Georgia 30281
Principal Investigator: Vincent Galan, M.D.
Phone: 770-771-6580
?
mi
from
Stockbridge, GA
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Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania 19053
Principal Investigator: Steven Rosen, M.D.
Phone: 215-740-2636
?
mi
from
Trevose, PA
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Precision Spine Care
Tyler, Texas 75701
Principal Investigator: Aaron Calodney, M.D.
Phone: 903-531-0566
?
mi
from
Tyler, TX
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The Pain Management Center
Voorhees, New Jersey 08043
Principal Investigator: Youssef Josephson, DO
Phone: 267-255-9298
?
mi
from
Voorhees, NJ
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Center for Interventional Pain & Spine
Wilmington, Delaware 19803
Phone: 844-365-7246
?
mi
from
Wilmington, DE
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