Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial
Phase: NA
Conditions: Chronic Pain
Sponsor: Boston Scientific Corporation

 
 
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Blue Box Study 
Study to Characterize the Effects of Programming Spinal Cord Stimulation (SCS) in 
Patients Undergoing a Boston Scientific (BSC) SCS Temporary Trial 
 
CLINICAL INVESTIGATION PLAN 
 
 
 
Sponsored By 
Boston Scientific Corporation 
Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
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Blue Box Clinical Study Protocol
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Confidential 
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Contact Information 
Role 
Contact 
Clinical Contact 
Kristen Lechleiter, M.S. 
Principal Clinical Research Scientist 
Boston Scientific Corporation 
Neuromodulation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
United States of America 
Kristen.lechleiter@bsci.com 
1-602-300-8267
Coordinating 
Not applicable
Principal 
Investi2:ators 
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Blue Box Clinical Study Protocol 
Boston Scientific Confidential. Unauthorized use is prohibited. 

 
Confidential 
 Form/Template 90702637 Rev/Ver AL 
Blue Box Protocol, 91153461 Rev/Ver C 
Page 9 of 48 
 
4. Introduction 
4.1. 
Chronic Pain 
Chronic pain is a significant world-wide complaint and consumes considerable healthcare 
resources and heavily impacts quality of social and working life for many.  A 2001 European 
investigation showed that 30% of patients treated in primary care facilities were treated by a 
physician for a pain complaint, and 37% of those patients (11% of total) suffered from chronic 
pain (Hasselstrom, Liu-Palmgren, & Rasjo-Wraak, 2002).  More recently an epidemiological 
study conducted in Scotland found the prevalence of chronic pain to be 48%, 8% of which is of 
neuropathic origin.  The authors concluded that chronic pain is more prevalent than what previous 
studies have suggested (Torrance, Smith, Bennett, & Lee, 2006).  In a separate European study 
done in 2006, 19% of adults surveyed reported suffering from chronic pain (Breivik, Collett, 
Ventafridda, Cohen, & Gallacher, 2006).  
 
In the 2010 report of the health and status of the nation, Health, the U.S. Center for Disease 
Control and Prevention reports that over 28% of adults suffer from non-fleeting low-back pain.  
In patients with low-back pain, approximately half of the patients reported limitation in at least 
one basic action from the following list:  movement difficulty, emotional difficulty, sensory 
difficulty, cognitive difficulty, self-care limitation, social limitation, or work limitation (National 
Center for Health Statistics, 2011). 
 
Chronic pain can lead to a number of co-morbidities, including reduced health-related quality of 
life, reduced ability to engage in activities of daily living, increased disability, increased 
emotional depression, and weight gain due to the adoption of a sedentary lifestyle. 
4.2. 
Spinal Cord Stimulation  
Spinal cord stimulation (SCS) is a treatment option for chronic pain that has generally been 
reserved for patients who have failed multiple, and sometimes all, conservative chronic pain 
therapies.  With SCS, an implanted pulse generator (IPG) delivers electrical current to a lead(s) 
implanted in the epidural space at spinal level(s) where access can be obtained neural structures 
that are implicated in the chronic pain circuits.   Electrically stimulating these nerves creates a 
comfortable tingling sensation, known as paresthesia, that can be directed to the painful location 
to mask the sensation of pain (Kumar et al., 2006).  
SCS is effective for neuropathic pain associated with a variety of conditions, including failed back 
surgery syndrome (FBSS), which is the most common condition associated with chronic pain 
(Carter et al., 2004, Taylor et al., 2004).  For best pain relief, the paresthesia must be programmed 
to overlap the regions of pain (North et al., 1990). To achieve overlap, the electrode contacts are 
programmed based on the patient’s feedback to various combinations of stimulation parameters 
such as polarities, pulse rate, amplitude, and pulse width.   
Two randomized controlled trials (RCTs) have been conducted on the use of SCS to treat patients 
with FBSS. Each study demonstrated the superiority of SCS compared with the alternative 
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