Back to results

Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Primary Purpose

Back Pain, Chronic Pain, Pain in Leg, Unspecified

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Precision Spinal Cord Stimulation System

Artisan Surgical Lead

About this trial

This is an interventional treatment trial for Back Pain focused on measuring Pain, Neurostimulation, Leg Pain, Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South Carolina
Neurosurgical Specialist

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Precision Spinal Cord Stimulation

Arm Description

Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead

Outcomes

Primary Outcome Measures

Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation

Secondary Outcome Measures

Full Information

NCT ID

NCT00386724

First Posted

October 10, 2006

Last Updated

November 21, 2020

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00386724

Brief Title

Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Insufficient Data Collected

Study Start Date

October 2006 (Actual)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Back Pain, Chronic Pain, Pain in Leg, Unspecified

Keywords

Pain, Neurostimulation, Leg Pain, Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Precision Spinal Cord Stimulation

Arm Type

Experimental

Arm Description

Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead

Intervention Type

Device

Intervention Name(s)

Precision Spinal Cord Stimulation System

Other Intervention Name(s)

PRECISION Spinal Cord Stimulator System

Intervention Description

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

Intervention Name(s)

Artisan Surgical Lead

Other Intervention Name(s)

Artisan surgical lead with PRECISION System.

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction in Baseline Back Pain Severity as Measured at 3 Months Post-activation

Time Frame

3 months post-activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roshini Jain

Organizational Affiliation

Boston Scientific Neuromodulation Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Neurosurgical Specialist

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

We'll reach out to this number within 24 hrs