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

Official Title: “Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain”

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.

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.

Intervention(s) in this Clinical Trial

• Device: Precision for Spinal Cord Stimulation
  • 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.

Primary Measures

• Reduction in baseline back pain severity as measured at 3 months post-activation.
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Leg pain and overall pain severity at 3 months post-activation as compared to baseline
  • Time Frame: 3 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Boston Scientific Corporation Industry

Overall Clinical Trial Officials and Contacts

Grant Skdimore, MD Principal Investigator Neurological Specialist  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00386724

Study ID Number: SCS0406

ClinicalTrials.gov Identifier: NCT00386724

Health Authority: United States: Institutional Review Board