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Effect of Pulse Width With Spinal Cord Stimulation

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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Chronic Pain Back Pain Device: Precision Phase 4

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Pulse Width on the Treatment of Chronic Low Back Pain With Spinal Cord Stimulation
Study Start Date : November 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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"


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00399516


Locations
United States, Alabama
Comprehensive Pain Management and Rehabilitation
Daphne, Alabama, United States, 36526
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Thomas Yearwood, MD Comprehensive Pain and Rehabilitation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00399516     History of Changes
Other Study ID Numbers: SCS0706
First Posted: November 15, 2006    Key Record Dates
Results First Posted: April 4, 2012
Last Update Posted: April 4, 2012
Last Verified: March 2012

Keywords provided by Boston Scientific Corporation:
Pain
Neurostimulation
Back pain
Chronic Pain

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms