Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

This study has been terminated.
(Insufficient Data Collected)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00386724
First received: October 10, 2006
Last updated: August 1, 2013
Last verified: August 2013

October 10, 2006
August 1, 2013
October 2006
August 2008   (final data collection date for primary outcome measure)
Reduction in baseline back pain severity as measured at 3 months post-activation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Reduction in baseline back pain severity as measured at 3 months post-activation.
Complete list of historical versions of study NCT00386724 on ClinicalTrials.gov Archive Site
Leg pain and overall pain severity at 3 months post-activation as compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Leg pain and overall pain severity at 3 months post-activation as compared to baseline;
  • Back, leg, and overall pain severity at 6 and 12 months post-activation as compared to baseline;
  • Pain/paresthesia overlap;
  • Quality of life;
  • Measure of depression and function.
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Back Pain
  • Chronic Pain
  • Pain in Leg, Unspecified
  • 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.
    Other Name: PRECISION Spinal Cord Stimulator System
  • Device: Artisan Surgical Lead
    Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
    Other Name: Artisan surgical lead with PRECISION System.
Active Comparator: Precision Spinal Cord Stimulation
Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead
Interventions:
  • Device: Precision Spinal Cord Stimulation System
  • Device: Artisan Surgical Lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00386724
SCS0406
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Grant Skdimore, MD Neurological Specialist
Boston Scientific Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP