Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode
|Back Pain Chronic Pain Pain in Leg, Unspecified||Device: Precision Spinal Cord Stimulation System Device: Artisan Surgical Lead||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain|
- Reduction in baseline back pain severity as measured at 3 months post-activation. [ Time Frame: 3 months ]
- Leg pain and overall pain severity at 3 months post-activation as compared to baseline [ Time Frame: 3 months ]
|Study Start Date:||October 2006|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Precision Spinal Cord Stimulation
Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead
Device: Precision Spinal Cord Stimulation System
Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain.
Other Name: PRECISION Spinal Cord Stimulator SystemDevice: Artisan Surgical Lead
Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
Other Name: Artisan surgical lead with PRECISION System.
The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed in parallel at T8-T9 vertebral levels. A common problem after surgery is the migration of leads from the initial implanted site, the consequence of which is inadequate pain relief. Anecdotal reports suggest that the paddle electrode can eliminate some of the problems associated with lead migration by providing a constant distance between the parallel electrodes. Furthermore, it has been reported to provide superior pain relief and paresthesia coverage.
This study aims to evaluate pain and paresthesia coverage by placing a paddle lead. Patients invited to participate in this study will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386724
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Virginia|
|Norfolk, Virginia, United States, 23510|
|Principal Investigator:||Grant Skdimore, MD||Neurological Specialist|