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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Pain
Chronic Pain
Back Pain
Intervention: Device: Precision

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
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
Lost to Follow-up                2 

  Baseline Characteristics

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
Spinal Cord Stimulation Programming Parameters Spinal Cord Stimulation (SCS) Treatment Group

Baseline Measures
   Spinal Cord Stimulation Programming Parameters 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   17 
>=65 years   4 
[Units: Years]
Mean (Standard Deviation)
 53.4  (12.9) 
[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

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

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

Responsible Party: Boston Scientific Corporation Identifier: NCT00399516     History of Changes
Other Study ID Numbers: SCS0706
First Submitted: November 13, 2006
First Posted: November 15, 2006
Results First Submitted: February 13, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 4, 2012