Clinical Trial: OPTIONS Spinal Cord Stimulation Programming Parameters
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Multi-center, Open-label Study of Programming Options in Spinal Cord Stimulation.
Brief Summary: The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
Detailed Summary:
Prospective, multi-center, open-label study evaluating programming options in spinal cord stimulation on pain relief. All eligible subjects will undergo a Spinal Cord Stimulation (SCS) device trial that includes an intraoperative programming trial. Subjects experiencing a positive response to the programming parameters (improvement in average overall pain relief) during the trial from baseline will move forward with a permanent implant. Those not reporting a positive response to the programming parameters will be exited from the study.
The subjects will complete a number of assessment worksheets to characterize their Quality of Life and function and the level of pain they are experiencing from the baseline to 3 months post neurostimulation trial.
Sponsor: MedtronicNeuro
Current Primary Outcome: Change in average overall pain as measured by the diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire [ Time Frame: From baseline to 3 months post device activation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient Global Impression of Change [ Time Frame: From baseline to 3 months post device activation ]
Original Secondary Outcome: Same as current
Information By: MedtronicNeuro
Dates:
Date Received: July 14, 2015
Date Started: July 2015
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016