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Spinal Cord Stimulation for Low Back Pain

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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

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

U.S. FDA Resources


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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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


  Show 30 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Ramsin Benyamin, MD Millenium Pain Center

Responsible Party: Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00205868     History of Changes
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:
Back Pain
Low Back Pain
Chronic Pain
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes