Spinal Cord Stimulation (SCS) Dosing Study

Completed · Phase 4

Conditions studied: Back Pain, Leg Pain

In brief

This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.

Key facts

Study ID

NCT03284411

Run by

MedtronicNeuro

People needed

30

Starts

2017-11-01

Expected to finish

2019-03-15

Last updated by the study team

2020-04-15

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22 years of age or older
• Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
• Has approproate SCS settings
• Willing and able to provide signed and dated informed consent
• Capable of comprehending and consenting in English
• Capable of getting into the supine and sitting positions
• Willing and able to comply with all study procedures and visits
• On stable (no change in dose, route, or frequency) prescribed pain medications

You may not qualify if…

• Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
• Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
• Implanted with quadripolar lead
• Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
• Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
• Has untreated major psychiatric comorbidity
• Has serious drug-related behavioral issues
• Has unresolved major issues of secondary gain

Where it is running

• Arizona Pain Doctors — Chandler, Arizona, United States
• Georgia Pain and Wellness Center — Lawrenceville, Georgia, United States
• Global Scientific Innovations — Evansville, Indiana, United States
• Goodman Campbell Brain and Spine — Indianapolis, Indiana, United States
• Kentuckiana Pain Specialists — Louisville, Kentucky, United States
• Drez One, LLC — Somerset, Kentucky, United States
• Regional Brain & Spine — Cape Girardeau, Missouri, United States
• Precision Spine Care — Tyler, Texas, United States
• Northwest Pain Care, Inc. — Spokane, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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