Effect of Pulse Width With Spinal Cord Stimulation

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. Identifier: NCT00399516
Recruitment Status : Completed
First Posted : November 15, 2006
Results First Posted : April 4, 2012
Last Update Posted : April 4, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

November 13, 2006
November 15, 2006
February 13, 2012
April 4, 2012
April 4, 2012
November 2006
October 2007   (Final data collection date for primary outcome measure)
Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) [ Time Frame: Within 6 months post-implantation ]
Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Effect of pulse width on reduction of pain.
Complete list of historical versions of study NCT00399516 on Archive Site
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  • Average pain severity;
  • Effect of pulse width on stimulation thresholds, paresthesia coverage, and perception.
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Effect of Pulse Width With Spinal Cord Stimulation
The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.

Patients invited to participate in this study will have recently been implanted with the Precision system, or 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.

Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Pain
  • Chronic Pain
  • Back Pain
Device: Precision
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
  • Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
  • 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 any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
  • Have any other chronic pain condition likely to confound evaluation of study endpoints.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Boston Scientific Corporation
Boston Scientific Corporation
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Principal Investigator: Thomas Yearwood, MD Comprehensive Pain and Rehabilitation
Boston Scientific Corporation
March 2012

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