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Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03345472•MedtronicNeuro

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (20)

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

Key Dates

Start Date

November 30, 2017

Primary Completion Date

February 4, 2019

Completion Date

October 21, 2019

Last Updated

November 3, 2020

Enrollment

175

ACTUAL participants

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation System

DEVICE

Optimization of NIBS for Treatment of Addiction

NCT04379115

Opioid-use DisorderChronic Pain

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RECRUITINGNA

VR Mindfulness Training for Veterans With SCI

NCT06587607

Spinal Cord InjuryChronic Pain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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