An Implantable Spinal Cord Stimulation Pain Management System

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: September 13, 2005
Last updated: September 26, 2012
Last verified: September 2012
Results First Received: March 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Pain
Pain, Intractable
Back Pain
Failed Back Surgery Syndrome
Intervention: Device: Precision SCS

  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
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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 (SCS) Group Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered "trial" durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System.

Participant Flow:   Overall Study
    Spinal Cord Stimulation (SCS) Group  
STARTED     65  
COMPLETED     44  
Only received temporary implants                 16  
Withdrawal by Subject                 5  

  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
Spinal Cord Stimulation (SCS) Group Precision Spinal Cord Stimulation therapy group

Baseline Measures
    Spinal Cord Stimulation (SCS) Group  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     54  
>=65 years     11  
[units: years]
Mean (Standard Deviation)
  52  (14)  
[units: participants]
Female     26  
Male     39  
Region of Enrollment  
[units: participants]
United States     65  

  Outcome Measures

1.  Primary:   Change in Visual Analog Scale (VAS) Score From Baseline to 2 Week Post Initial Fitting.   [ Time Frame: 2 weeks post initial fitting ]

  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: Natalie Bloom Lyons
Organization: Boston Scientific Corporation
phone: 763-228-9040

Responsible Party: Boston Scientific Corporation Identifier: NCT00205855     History of Changes
Other Study ID Numbers: CR-S-003
Study First Received: September 13, 2005
Results First Received: March 5, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration