Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

NCT ID: NCT00386724

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-08-31

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.

Conditions

Back Pain; Chronic Pain; Pain in Leg, Unspecified

Keywords

Pain; Neurostimulation; Leg Pain; Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Precision Spinal Cord Stimulation

Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead

Group Type: EXPERIMENTAL

Precision Spinal Cord Stimulation System

Intervention Type: DEVICE

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.

Artisan Surgical Lead

Intervention Type: DEVICE

Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.

Interventions

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.

Intervention Type: DEVICE

Artisan Surgical Lead

Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.

Intervention Type: DEVICE

Other Intervention Names

PRECISION Spinal Cord Stimulator System; Artisan surgical lead with PRECISION System.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roshini Jain

Role: STUDY_DIRECTOR

Boston Scientific Neuromodulation Corporation

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Neurosurgical Specialist

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

SCS0406

Identifier Type: -

Identifier Source: org_study_id