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

This study has been terminated.
(Insufficient Data Collected)
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00386724
First received: October 10, 2006
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Back Pain
Chronic Pain
Lower Extremity Pain
 Device: Precision for Spinal Cord Stimulation
Device: Artisan Surgical Lead
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of the Precision Spinal Cord Stimulation System With the Artisan Paddle Electrode in Patients With Back or Lower Extremity Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Reduction in baseline back pain severity as measured at 3 months post-activation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leg pain and overall pain severity at 3 months post-activation as compared to baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: PRECISION Spinal Cord Stimulator System (Precision 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 paddle electrode approved for use as part of the PRECISION System.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386724

Locations
United States, Georgia
Research Center
Augusta, Georgia, United States, 30912
United States, South Carolina
Research Center
Charleston, South Carolina, United States, 29425
United States, Virginia
Research Center
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Grant Skdimore, MD Neurological Specialist
  More Information

No publications provided

Responsible Party: Lyn.Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00386724     History of Changes
Other Study ID Numbers: SCS0406
Study First Received: October 10, 2006
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Pain
Neurostimulation
Leg Pain
Back Pain

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013