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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

September 13, 2005
September 21, 2005
October 13, 2008
December 2004
November 2007   (Final data collection date for primary outcome measure)
  • Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ]
  • Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use. [ Time Frame: 1 year ]
  • Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use.
  • Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use.
Complete list of historical versions of study NCT00205868 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
Spinal Cord Stimulation for Low Back Pain
Effectiveness of the Precision Spinal Cord Stimulation System in Patients With Failed Back Surgery Syndrome and Axial Low Back Pain

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Pain
Device: Precision Spinal Cord Stimulation System
Stimulation on throughout study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
200
December 2007
November 2007   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00205868
PM -SCS -120904
No
Not Provided
Not Provided
Lyn Pimentel, Clinical Project Manager, Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Ramsin Benyamin, MD Millenium Pain Center
Boston Scientific Corporation
October 2008

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