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Effect of Pulse Width With Spinal Cord Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00399516
First received: November 13, 2006
Last updated: March 7, 2012
Last verified: March 2012

November 13, 2006
March 7, 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Not Provided
  • Average pain severity;
  • Effect of pulse width on stimulation thresholds, paresthesia coverage, and perception.
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Pain
  • Chronic Pain
  • Back Pain
Device: Precision
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
21
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00399516
SCS0706
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
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