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Spinal Cord Stimulation for Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00205868
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
Boston Scientific Corporation

Brief Summary:

The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain.

Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.


Condition or disease Intervention/treatment Phase
Chronic Pain Device: Precision Spinal Cord Stimulation System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain
Study Start Date : December 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Precision Spinal Cord Stimulation System
    Stimulation on throughout study


Primary Outcome Measures :
  1. Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ]
  2. Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage of patients who achieve a significant clinical reduction in back pain defined as >50% reduction in VAS score with stimulation compared with no stimulation [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eligible for spinal cord stimulation as labeled in the FDA approval for the Precision(R) Spinal Cord Stimulator by Advanced Bionics;
  2. Age ≥18 years;
  3. Have pain of neuropathic origin;
  4. Have chronic pain secondary to surgical spine procedure or intractable low back pain with or without leg pain for at least 3 months and not responding to less invasive clinical procedures.

Exclusion Criteria:

1. Enrollment in any research that would conflict with study requirements.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205868


Locations
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United States, Alabama
Research Center
Cullman, Alabama, United States, 35055
Research Center
Daphne, Alabama, United States, 36526
Research Center
Huntsville, Alabama, United States, 35801
United States, Arizona
Research Center
Mesa, Arizona, United States, 85206
United States, California
Research Center
Los Angeles, California, United States, 90095
Research Center
Pasadena, California, United States, 91105
Research Center
San Diego, California, United States, 92108
United States, Colorado
Research Center
Westminster, Colorado, United States, 80401
United States, Florida
Research Center
Jacksonville, Florida, United States, 32224
Research Center
Jupiter, Florida, United States, 33477
United States, Idaho
Research Center
Lewiston, Idaho, United States, 83501
United States, Illinois
Research Center
Bloomington, Illinois, United States, 61701
Research Center
Chicago, Illinois, United States, 60611
Research Center
Oak Brook, Illinois, United States, 60707
United States, Indiana
Research Center
Merrillville, Indiana, United States, 46410
Research Center
Valparaiso, Indiana, United States, 46410
United States, Massachusetts
Research Center
Boston, Massachusetts, United States, 02215
Research Center
Pittsfield, Massachusetts, United States, 01201
United States, Minnesota
Research Center
Rochester, Minnesota, United States, 55904
United States, Montana
Research Center
Billings, Montana, United States, 59101
United States, North Carolina
Research Center
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Research Center
Hamilton, Ohio, United States, 45011
United States, Oregon
Research Center
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Research Center
Allentown, Pennsylvania, United States, 18104
Research Center
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Research Center
Spartanburg, South Carolina, United States, 29302
United States, Utah
Research Center
Murray, Utah, United States, 84107
Research Center
Provo, Utah, United States, 84604
United States, Wisconsin
Research Center
Cudahy, Wisconsin, United States, 53220
Research Center
Rice Lake, Wisconsin, United States, 54868
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Ramsin Benyamin, MD Millenium Pain Center

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Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205868    
Other Study ID Numbers: PM -SCS -120904
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Keywords provided by Boston Scientific Corporation:
Back Pain
Low Back Pain
Chronic Pain
Spinal Cord Stimulation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms