An Implantable Spinal Cord Stimulation Pain Management System

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: NCT00205855
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : October 26, 2012
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Pain
Pain, Intractable
Back Pain
Failed Back Surgery Syndrome
Intervention: Device: Precision SCS

  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 (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
Only received temporary implants                16 
Withdrawal by Subject                5 

  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 (SCS) Group Precision Spinal Cord Stimulation therapy group

Baseline Measures
   Spinal Cord Stimulation (SCS) Group 
Overall Participants Analyzed 
[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

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: 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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: March 5, 2012
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012