Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Not Applicable

Terminated

Interventions: Device: Precision Spinal Cord Stimulation System
Device: Artisan Surgical Lead

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy;
Be 18 years of age or older;
Be willing and able to comply with all study related procedures and visits;
Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria

Have low back pain as the primary complaint;
Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints;
Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.

Arm && Interventions

Group	Intervention	Description
Precision Spinal Cord Stimulation	Precision Spinal Cord Stimulation System	Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead
Precision Spinal Cord Stimulation	Artisan Surgical Lead	Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead

Primary Outcome Measures

Name	Time	Method
Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation	3 months post-activation

Secondary Outcome Measures

Name	Time	Method

Locations (2): Neurosurgical Specialist
🇺🇸
Norfolk, Virginia, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States