NCT00386724

Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.

Detailed description

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.

Conditions

• Back Pain
• Chronic Pain
• Pain in Leg, Unspecified

Interventions

Type	Name	Description
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.
DEVICE	Artisan Surgical Lead	Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-10-12
• Last updated: 2020-12-17
• Results posted: 2020-12-17

Locations

2 sites across 1 country: United States