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
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Pain
Chronic Pain
Back Pain
Intervention: Device: Precision

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)

Participant Flow:   Overall Study
    Spinal Cord Stimulation Programming Parameters  
STARTED     21  
COMPLETED     19  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) Treatment Group

Baseline Measures
    Spinal Cord Stimulation Programming Parameters  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  53.4  ± 12.9  
Gender  
[units: participants]
 
Female     8  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures

1.  Primary:   Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS)   [ Time Frame: Within 6 months post-implantation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brad Hershey, MS
Organization: Boston Scientific
phone: (661) 949-4828
e-mail: Brad.Hershey@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00399516     History of Changes
Other Study ID Numbers: SCS0706
Study First Received: November 13, 2006
Results First Received: February 13, 2012
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board