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

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT03345472

Run by

MedtronicNeuro

People needed

175

Starts

2017-11-30

Expected to finish

2019-10-21

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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