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 ]

Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).


Original Primary Outcome: Same as current

Current Secondary Outcome: Patient Global Impression of Change [ Time Frame: From baseline to 3 months post device activation ]

Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).


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