NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement
Conditions: Chronic Pain, Sciatica, Failed Back Surgery Syndrome
Sponsor: St. Luke's Hospital, Pennsylvania

 
 
 
Clinical Protocol 
 
 
Approval Date: 
TBD 
 
Protocol Title: 
NAPS (Non-awake versus Awake Placement of Spinal cord stimulators) Study 
for the evaluation of awake and non-awake methods of SCS paddle lead 
placement 
 
 
Funding Sponsor: 
St. Jude Medical 
  
6901 Preston Rd.   
Plano, TX 75024 
 
Coordinating Investigator: 
Steven Falowski, MD 
 
St. Luke’s Neurosurgical Associates 
 
701 Ostrum St 
 
Suite 302 
 
Bethlehem, PA 18015 
 
Office 484-526-6000 
 
Fax 484-526-9410 
 
Participating Investigators:  
Ashwini Sharan, MD 
Thomas Jefferson University Hospital 
Department of Neurosurgery 
909 Walnut Street 
2nd Floor 
Philadelphia, PA 19107 
 
Darren L. Jacobs, DO 
Neurosurgery, Geisinger Medical Center 
100 N Academy Ave 
Danville, PA 17822 
 
James McInerney, MD 
Penn State Hershey Neurosurgery 
Milton S. Hershey Medical Center 
30 Hope Drive, Building B, Suite 1200 
P.O. Box 859 
Hershey, PA 17033 
 
 
Approval Signatures: 
   
 
 
Investigator 
 
 
 
 
 
 
Date    
 
 
 
 

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Table of Contents 
Approval Signatures: ....................................................................................................................... 1 
Confidentiality Statement ............................................................................................................... 4 
1. 
Introduction .............................................................................................................................. 6 
2. 
Objectives/Endpoints ............................................................................................................... 7 
2.1. 
Primary Objective ............................................................................................ 7 
2.2. 
Secondary Objective ........................................................................................ 7 
2.3. 
Primary Variables ............................................................................................ 7 
2.4. 
Secondary Variables ........................................................................................ 7 
2.5. 
Additional Data ................................................................................................ 7 
3. 
Study Design ............................................................................................................................. 8 
3.1. 
Design ............................................................................................................. 8 
3.2. 
Justification for study given risks/benefit outcome ......................................... 10 
4. 
Study Devices ......................................................................................................................... 10 
5. 
Patient Selection ..................................................................................................................... 11 
5.1. 
Inclusion Criteria ............................................................................................ 11 
5.2. 
Exclusion Criteria ........................................................................................... 11 
6. 
Patient Assignment to Procedure ......................................................................................... 11 
7. 
Methods and Procedures ....................................................................................................... 12 
7.1. 
Informed Consent .......................................................................................... 12 
7.2. 
Screening ...................................................................................................... 12 
7.3. 
Randomization ............................................................................................... 12 
7.4. 
Baseline Evaluation ....................................................................................... 12 
7.5. 
Medication Collection ..................................................................................... 12 
7.6. 
SCS Permanent System Implantation Guidelines .......................................... 12 
7.6.1. Lead Placement for Awake Arm ................................................. 13 
7.6.2. Lead Placement for Non-awake Arm .......................................... 13 
7.6.3. Pulse Generator Placement and Data Collection for Both Arms 13 
7.7. 
Postoperative Management and Instruction ................................................... 13 
7.8. 
Device Activation ........................................................................................... 14 
7.8.1. Programming Parameters .......................................................... 14 
7.9. 
Blinding .......................................................................................................... 14 
7.10. Follow-up Visits ............................................................................................. 14 
7.10.1. 6 Week Visit ........................................................................... 15 
7.10.2. 24 Week Visit ......................................................................... 15 
7.10.3. Unscheduled Visit .................................................................. 15 
7.11. Outcome Measures ....................................................................................... 15 
7.11.1. Characterization of Procedure Time ...................................... 15 
7.11.2. Adverse Events ...................................................................... 16 
7.11.3. Coverage ............................................................................... 16 
7.12. Additional Data .............................................................................................. 16 
Pain Evaluation Form............................................................................................... 16 
8. 
Adverse Events (AEs) ............................................................................................................ 17 
8.1. 
AE Definitions ................................................................................................ 17 
8.2. 
AE Recording ................................................................................................ 18 
8.3. 
Reporting AEs ............................................................................................... 18 
8.4. 
Anticipated Adverse Events and Complications ............................................. 18 
8.5. 
AE Classification ............................................................................................ 19 
8.5.1. Severity Rating ........................................................................... 19 
8.5.2. Relationship to Device/Procedure .............................................. 20 

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9. 
Data Review and Database Management ............................................................................ 20 
9.1. 
Site Monitoring ............................................................................................... 20 
9.2. 
Data Collection .............................................................................................. 20 
9.3. 
Database Management and Quality Control .................................................. 21 
10. Data Analysis .......................................................................................................................... 21 
10.1. Statistical Plan ............................................................................................... 21 
10.2. Sample Size Justification ............................................................................... 21 
10.3. Primary Analysis ............................................................................................ 22 
10.3.1. Procedure Time ..................................................................... 22 
10.3.2. Number of adverse events ..................................................... 22 
10.3.3. Procedure Time ..................................................................... 22 
10.4. Secondary Analysis ....................................................................................... 22 
10.4.1. Paresthesia coverage ............................................................ 22 
10.5. Additional Analysis ......................................................................................... 23 
10.6. Data Sets ....................................................................................................... 23 
11. Withdrawal of Patients from Study ..................................................................................... 23 
12. Modification of Protocol ........................................................................................................ 24 
13. Discontinuation of Study ....................................................................................................... 24 
14. References ............................................................................................................................... 25 
15. Appendix A: Case Report Form Matrix .............................................................................. 26 
16. Appendix B: Patient Questionnaires .................................................................................... 27 
 

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Confidentiality Statement 
 
The confidential information in the following document is provided to you as an Investigator, potential 
Investigator, or Consultant for review by you, your staff and an appropriate Institutional Review Board 
or Independent Ethics Committee. By accepting the document you agree that the information contained 
herein will not be disclosed to others without written authorization from Coordinating Investigator or 
from St. Jude Medical, except to the extent necessary to obtain informed consent from those persons to 
whom the products may be administered. 
 

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Protocol Summary 
Title: 
NAPS (Non-Awake versus Awake Placement of Spinal cord stimulators) 
Study for the  evaluation of awake and non-awake methods of  SCS paddle 
lead placement 
Study Devices: 
Eon Mini™ or Eon™ neurostimulation system with the Penta™ paddle leads 
or the Lamitrode C-series™ paddle leads. 
Objectives: 
Determine whether non-awake placement of spinal cord stimulators with 
electromyography (EMG) neuromonitoring is comparable to awake placement 
for achieving paresthesia coverage in chronic pain patients.  Determine 
whether non-awake placement reduces procedure time, risk for revision, risk 
for complications.  
Patient Population: 
Patients with successful spinal cord stimulator (SCS) trials presenting for 
permanent implantation of a paddle electrode in the thoracic region 
Population Size: 
Approximately 50 
Structure: 
The study is designed as a prospective, multicenter, parallel design, non-
randomized, non-blinded, 6-month study.   
Method of Assignment: 
All patients who comply with the inclusion/exclusion criteria will be enrolled 
chronologically. 
Randomization: 
There will be no randomization of the patients. Patients recruited and enrolled 
at St. Luke’s Neurological Associates or Thomas Jefferson University   will 
undergo implantation under general anesthesia with EMG neuromonitoring 
for testing of the distribution of induced paresthesia (“non-awake”). Patients 
recruited and enrolled at Geisinger or Milton S. Hershey Medical Centers will 
undergo implantation of the device in an awake operation with local 
anesthetic and patient interaction for testing of the distribution of the induced 
paresthesia (“awake”).   
Statistical Analysis: 
The primary endpoints will be procedure time, rates of adverse events, 
specifically lead revisions, and patient satisfaction. An additional endpoint 
will be the proportion of painful regions covered by paresthesia in non-awake 
compared to awake patients  
Adverse Events 
All device/procedure-related and all serious adverse events that occur and are 
volunteered by the patient and solicited by the site staff will be collected. 

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1. Introduction   
Spinal cord stimulation (SCS) is an adjustable, non-destructive, therapy in which an electrical 
current is applied to the spinal cord for management of neuropathic pain.  Leads are placed in the 
epidural space, which apply electrical stimulation to the spinal cord. It has been used for many 
years and has proven to be effective in the treatment of chronic, intractable pain including failed 
back surgery syndrome CRPS, phantom limb pain, cancer pain, peripheral vascular disease, and 
ischemic limb pain (Burchiel et al., 1996; Cameron, 2004; Kemler, de Vet, Barendse, van den 
Wildenberg, & van Kleef, 2008; Khan, Raza, & Khan, 2005; Turner, Loeser, Deyo, & Sanders, 
2004).  
The success of the therapy relies on the ability to create an overlap between the pain areas and the 
device-induced paresthesia. Lead placement has historically been done under awake conditions, 
using direct feedback from the patient in order to define adequate paresthesia coverage. The 
awake operation is performed while the patient is under local anesthesia, which is very stressful 
for the patient and predisposes them to movement. This can lead to decreased patient satisfaction, 
equipment migration, undesired stimulation effects, and treatment failure. 
Implantation under general anesthesia using electromyography (EMG) responses to determine 
paresthesia coverage may offer advantages over the awake procedure.  This “non-awake” 
technique is potentially more comfortable for the patient and may carry less risk for revision. 
Recently, several retrospective studies have found that the non-awake procedure is safe and at 
least as efficacious in producing adequate paresthesia coverage as the awake procedure (Air, 
Toczyl, & Mandybur, 2012; Falowski et al., 2011; Shils & Arle, 2012).  Falowski et al. found that 
the non-awake procedure resulted in the same or fewer revisions as the awake procedure.  Shils 
observed a 30 minutes (33%) reduction in procedure time. 
These studies are promising, yet there is a need for a prospective study to determine the 
equivalency or benefit of the non-awake procedure.  The purpose of the proposed clinical study is 
to collect data necessary to demonstrate the safety and efficacy of non-awake implantation of 
SCS paddle leads compared to the awake procedure. The study is designed to evaluate whether 
non-awake placement reduces procedure time, complication rates, and/or revision rates while 
offering comparable paresthesia coverage as the awake procedure. 

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2. Objectives/Endpoints  
2.1. 
Primary Objective 
To demonstrate the safety and efficacy of a non-awake implantation method (EMG 
neuromonitoring) of a SCS paddle lead as compared to an awake implantation method 
(with local anesthesia and patient feedback). 
2.2. 
Secondary Objective 
To demonstrate that implantation non-awake and awake methods result in comparable 
paresthesia coverage of painful regions. 
2.3. 
Primary Variables 
• Procedure time 
• Number and type of adverse events 
• Number of revisions 
2.4. 
Secondary Variables 
• Pain mapping and paresthesia coverage 
2.5. 
Additional Data 
• Demographics: gender, age, height, weight, ethnicity, marital status 
• Pain history: primary diagnosis, pain duration, pain etiology, prior treatments  
• Medication usage including rescue medication  
• Pain quality as assessed by the Short-Form McGill Pain Questionnaire version 2  
• Quality of life as assessed by EuroQol (EQ-5D) generic health index questionnaire 
• Patient global impression of satisfaction with device implantation compared to 
trial system implantation. 
• Surgery and device information 
• Programming data 
• Patient reported perception of pain relief. 
• Responder classification for average daily overall pain.  Responders are classified 
as patients with ≥30% or ≥50% reduction in pain. 
 
 
 

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3. Study Design 
3.1. Design 
This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 
6-month study.  A minimum of 50 patients will be implanted from up to 4 active sites, 
coordinated by a single lead investigator.  
 
Patients who have had a successful SCS trial and are indicated for permanent implantation will 
be approached to participate in this study prior to permanent implantation.  Patients will be 
recruited and enrolled by physicians at any one of the involved sites.  Each Investigator will 
only use one method (awake or non-awake) according to his/her typical practice.  Patients will 
receive treatment from their enrolling physician. 
 
 
 

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Table 1: Study Schedule 
Timing of visit 
Activities at visit 
Case Report Forms 
Screening and 
Informed 
Consent 
 (may be 
immediately after 
Trial System 
Explant) 
Patient evaluated for eligibility   
Patient signs informed consent 
 
Schedule patient for baseline evaluation at 
treatment site 
Enrollment Form 
Inclusion/Exclusion Criteria 
Form  
 
Baseline 
Evaluation 
7-28 days after 
screening 
Patient completes questionnaires  
Complete history and physical exam 
Record current medication use 
Collect patient reported data  
Baseline Self Evaluation Form 
Pain Location Form 
Pain Evaluation Form 
SF-MPQ-2 (Pain Quality) 
EQ-5D (Quality of life) 
Medication Form 
Permanent 
System 
Implantation  
 
 
Permanent system implantation  
Record any complications 
Record any changes in medication 
Discourage activation at discharge 
Save digital recording or EMG recording if 
system permits. 
Surgery Form 
Adverse Event Form 
Programming Form (if 
programmed at discharge) 
Medication Form 
Initial 
Programming 
Visit 
 
 
Record any complications 
Record any changes in medication 
Provide patient with the patient 
programmer and charging system 
Record patient’s global impression of 
satisfaction with the implant procedure. 
Programming Form 
Paresthesia Coverage Form 
Patient Global Impression Form  
Medication Form 
6 weeks 
42± 7 days after 
activation  
Record any complications 
Record any changes in medication 
Patient completes questionnaires  
Modify programming parameters (if 
necessary) 
Collect patient reported data 
Follow-up Visit Form 
Pain Evaluation Form 
Pain Location Form 
Programming Form 
SF-MPQ-2 (Pain Quality) 
EQ-5D (Quality of life) 
Paresthesia Coverage Form 
Medication Form 
24 weeks   
168 ± 14 days 
after activation  
 
 
Record any complications 
Record any changes in medication 
Patient completes questionnaires  
Modify programming parameters (if 
necessary) 
Collect patient reported data 
Follow-up Visit Form 
Pain Evaluation Form 
Pain Location Form 
Programming Form 
SF-MPQ-2 (Pain Quality)  
EQ-5D (Quality of life) 
Paresthesia Coverage Form 
Medication Form 
Unscheduled 
Visit (as needed) 
Record any unscheduled visit 
Record any changes in medication 
Record any other health care utilized 
Record any complications 
Unscheduled Visit Form 
Medication Form 
HCOR Form 
Adverse Event Form 

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Timing of visit 
Activities at visit 
Case Report Forms 
Record programming changes 
Record paresthesia changes 
Product Out of Service Form 
Programming Form 
Paresthesia Location Form 
Additional Surgery Form 
Exit and Withdrawal form 
 
3.2. Justification for study given risks/benefit outcome 
Spinal Cord Stimulation is a commercially available neurostimulation therapy available for 
treatment of chronic intractable pain of the trunk and/or limbs to patients today. Traditionally, 
SCS leads are placed in the epidural space while the patient is awake and able to give direct 
feedback in order to ensure adequate paresthesia coverage. Using EMG for lead implantation 
will allow the patient to be placed under general anesthesia and to be potentially more 
comfortable than during the awake procedure. The purpose of the proposed clinical study is to 
collect data necessary to make a direct comparison between the awake procedure and the non-
awake procedure using EMG.  
The Investigator will review the subject’s medical record to ensure that the subject complies 
with all inclusion/exclusion criteria. The target population consists of subjects indicated for a 
neurostimulation system. The present study will permit the physician to adhere to their standard 
of care for continued medication usage or any current treatment methods prior to enrollment. 
The risks and benefits are the same for these two lead placement techniques since the implant 
procedure is the same. No additional adverse events from non-awake placement are anticipated. 
Considering the severity of chronic pain and its debilitating effect on patients’ lives, spinal cord 
stimulation provides an alternative means of pain reduction with minimal risk for subjects who 
have exhausted other options. 
4. Study Devices 
All study devices are in commercial distribution in the United States and Europe as an aid in the 
management of chronic intractable pain of the trunk and/or limbs. St. Jude Medical (SJM) 
received FDA approval for the Eon Mini IPG system under the PMA P010032/S32 and Eon IPG 
system under the PMA P010032/S014. The Lamitrode leads received clearance under K990469 
(standard), K053250 (90 and 110cm), K033429 (C-Series), K022222 (S-Series), K063080 
(Tripole 8C, 16C, and Exclaim), K090907 (Penta) and K991784 (extensions). 
Any SJM market-cleared IPG may be used.  Any SJM market-cleared paddle lead may be used. 
Percutaneous leads may not be used. 
The Eon Rechargeable Systems consists of the following components: Model 3716 and 3788, 
Rechargeable Implanted pulse generator (IPG), Model 3851 Patient Programmer, Programming 
Wand, Patient Magnet, and Charging System. The Eon Neurostimulation Systems are intended to 
be used with SJM’s leads and extensions and their accessories currently on the market. 

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5.  
Patient Selection 
5.1. 
Inclusion Criteria 
Patients enrolled in this study must meet the following inclusion criteria: 
1. Patient is able to provide informed consent to participate in the study 
2. Patient is 18 years of age or older 
3. Patient has had a successful trial system and is presenting for permanent implantation 
of a paddle electrode in thoracic region. 
4. Patient is willing to cooperate with the study requirements including compliance with 
the treatment regimen and completion of all office visits 
5.2. 
Exclusion Criteria 
A patient will be excluded from participation in this study if they meet any one of the 
following criteria: 
1. Patient currently participating in a clinical investigation that includes an active 
treatment arm. 
2. Patient has an infusion pump or any implantable neurostimulation device 
3. Patient has an existing medical condition that is likely to require repetitive MRI 
evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, 
tumor) 
4. Patient has an existing medical condition that is likely to require the use of diathermy 
in the future 
5. Patient is immunocompromised 
6. Patient has documented history of allergic response to titanium or silicone 
7. Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or 
substance dependency in the 6 months prior to baseline data collection 
8. Female candidates of child bearing potential that are pregnant (confirmed by positive 
pregnancy test) 
6. Patient Assignment to Procedure   
Each patient who is willing to participate in the study, signs the informed consent, and complies 
with the inclusion/exclusion criteria will be enrolled in the study. Patients are considered enrolled 
in the study from the moment the patient has provided written informed consent. Each patient is 
enrolled chronologically on a patient enrollment log and given a patient number for the duration 
of the study.  
Patients will be enrolled in a 1:1 fashion to the method of surgical implantation, either awake or 
non-awake.  Patients will be treated by the enrolling physician. Patients recruited and enrolled at St. 
Luke’s Neurological Associates or Thomas Jefferson University will undergo implantation under general 
anesthesia with EMG neuromonitoring for testing of the distribution of induced paresthesia (“non-
awake”). Patients recruited and enrolled at Geisinger or Milton S. Hershey Medical Centers will undergo 
implantation of the device in an awake operation with local anesthetic and patient interaction for testing of 
the distribution of the induced paresthesia (“awake”). Each treatment arm will enroll a maximum of 30 
patients. No blinding is necessary for the purposes of assigned study arm. 

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7. Methods and Procedures 
7.1. 
Informed Consent 
Written informed consent must be obtained from all patients before recruitment into the 
study. All potential patients must be properly informed as to the purpose of the study and 
the potential risks and benefits known or that can be reasonably predicted or expected. 
The Investigator will retain the original copy of the Informed Consent Form signed by the 
patient and a duplicate will be provided to the patient. Only the consent form approved by 
the applicable Institutional Review Board (IRB) must be used.  
7.2. 
Screening  
The patient is evaluated for eligibility according to the inclusion/exclusion criteria. This 
evaluation will include a report of medical history, current medication regimen, and 
completion of questionnaires. At the end of the study visit after the investigator has 
determined that the patient is eligible for participation, study staff (e.g. study coordinator) 
collect the following information:   
• Enrollment form 
• Inclusion/exclusion form 
7.3. 
Randomization 
Patients will not be randomized.  . 
 
7.4. 
Baseline Evaluation  
Baseline measurements for the patient’s back and leg pain symptoms and general well-
being will be taken. This evaluation will include a report of medical history, current 
medication regimen, and completion of questionnaires.  Baseline evaluations include the 
following activities: 
• Collection of self-reported patient questionnaires: 
o Baseline self-evaluation form 
o Pain Location form 
o Pain Evaluation form 
o SF-MPQ-2 (Pain Quality) 
o EQ-5D (Quality of Life) 
o Medication Usage form  
 
7.5. 
Medication Collection  
Since certain non-pain medications have the ability to affect pain (e.g. certain 
antidepressants), we are collecting other medication usage outside of pain management 
medication. However, medications taken for common cold and allergies will not be 
recorded. 
7.6. 
SCS Permanent System Implantation Guidelines 
This section of the protocol provides a guideline for surgical implantation of the 
permanent system; however, implantation of the devices is performed at the discretion of 
the Investigator. The goal of the surgery is to enable coverage of the patient’s entire 

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painful area with stimulation. Patients will be prepped for surgical paddle lead placement 
via laminectomy or laminotomy according to usual practice at each implanting center, 
including anesthesia and customary intraoperative monitoring.  Initial lead placement is 
targeted anatomically based on patient-specific painful areas and trial lead experience. 
7.6.1. Lead Placement for Awake Arm 
Upon approximate lead positioning, the patient is brought to a conscious sedated state 
while maintaining local anesthetic.  Stimulation of the spinal cord through the paddle lead 
is accomplished with an external pulse generator, while communicating with the patient 
regarding paresthesia coverage of painful regions.  Upon satisfactory coverage, the IPG is 
implanted per 7.6.3 below. 
7.6.2. Lead Placement for Non-awake Arm 
The patient is maintained under general anesthesia for the full duration of the implant.  
Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal 
regions of pain are monitored.  Stimulation is delivered through the lead by an external 
pulse generator in order to elicit compound muscle action potentials (CMAPs) in the 
target regions.  Lead placement is targeted to have symmetric CMAPs (i.e. physiologic 
midline) and adequate coverage of the painful regions as described by Falowski et al. 
(Falowski et al., 2011).  Upon satisfactory coverage, the IPG is implanted per 7.6.3 below. 
7.6.3. Pulse Generator Placement and Data Collection for Both Arms 
The IPG is implanted by making a pocket incision at the desired location, and creating a 
subcutaneous pocket by blunt dissection. The pocket should be created so that the IPG is 
parallel to the skin surface. Subcutaneous tunnels are made from the lead incision site(s) 
to the IPG implantation site, using a tunneling tool. The leads/extension is tunneled to the 
IPG site. The lead/extension is connected to the IPG, the IPG is placed in the 
subcutaneous pocket, and all incisions are closed.  
Additional guidance on system placement is located in the device manuals distributed 
with each device. 
System implantation visit include recording the following information: 
• Device information 
• Collection of complications or changes in medication 
• Total operating room time 
• Skin-to-skin surgical time 
• Intraoperative programming time 
• Total fluoroscopy used (time and dose) 
• Final lead position 
7.7. 
 Postoperative Management and Instruction  
The physician will provide normal standard of care after implantation of the system, 
including standard post-operative monitoring. Instructions for wound care and monitoring 
will be provided to the patient by the implanting physician. Patients will be informed to 
report any adverse events or changes in medication to study personnel. Patients will be 
informed not to manipulate the leads after implantation because tissue erosion may occur. 
The patient will be sent home for a 2-3 week recovery period to let any swelling and/or 
post-operative pain subside prior to activation of SCS system, unless otherwise 

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determined by the installing investigator. During this time, the device may not be 
activated and the patient may not be provided with the Patient Programmer. Prophylactic 
antibiotic therapy may be instituted at the discretion of the Investigator. 
If the leads migrate during the study, the implanting physician will examine the area of 
implantation. The leads can be repositioned or re-implanted if mutually agreed upon by 
the physician and the patient. The patient and the implanting physician will make the 
mutual decision about any possible revision of the device based upon what is medically 
safe, what is desired by the patient, and what is in the patient’s best medical interests.  
If an infection occurs, standard medical practice suggests that the leads be removed and 
the patients undergo a standard course of oral antibiotics. Any infection or wound will be 
given time to heal before any re-implantation is attempted.  
If the device is completely explanted from the study patient for any reason and re-
implantation is not an option, then the patient will exit the study. 
7.8. 
Device Activation  
The permanent system device activation visit will occur approximately 2-3 weeks after 
permanent system implantation. At this visit, each patient will have their device 
programmed to comparable individualized programming parameters. All patients will 
receive a Patient Programmer that will enable him/her to activate the ON and OFF 
positions and adjust amplitude within the prescribed range.  
A map of paresthesia coverage is collected along with final programmed parameters, lead 
impedance, and device data.  Any changes in medications are noted as well. 
7.8.1. Programming Parameters  
The programming ranges are defined below to use as a guide for consistency in 
study programming. Ranges are provided due to differences in patient perception. 
Programming may vary in cases where coverage is difficult to obtain or the patient 
experiences uncomfortable stimulation.  
• Patients will be stimulated at supra-sensory threshold levels using Spinal Cord 
Stimulation leads (i.e. leads placed in the epidural space). Typical parameter 
ranges are pulse width of 150-350 µs and frequency of 20-80 Hz. Amplitude 
will be programmed according to individual patient perception and comfort 
and to a level that produces paresthesia for the patient.  
• Patient Global Impression Form  
Patient satisfaction with permanent implant procedure will be assessed on a 5 
point Likert scale. Patients will be asked to rate their satisfaction as very 
satisfied/ satisfied/ neither satisfied nor dissatisfied/ dissatisfied/ very 
dissatisfied as compared with their trial implantation procedure. 
7.9. 
Blinding 
The study is non-blinded.  
7.10. Follow-up Visits  
Patients will report to the office at the specified intervals below. Under the guidance of the 
Investigative team at each visit, SJM field representatives may assist with programming of 
the patient’s device as needed during the course of the study.  

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Missed visits and visits that occur outside of the specified time windows will be 
documented as protocol deviations.  
7.10.1. 6 Week Visit 
Patients will complete additional follow-up visits at 6 weeks for continued 
monitoring of the safety and efficacy of the therapy. All programming data will be 
captured on the appropriate case report form. 
A map of paresthesia coverage is collected along with programming parameters, 
lead impedance, and device data.  Any changes in medications will be recorded. 
Pain metrics to be collected are patient reported pain relief, NRS, and SF-MPQ.  
Quality of Life (EQ-5D) will also be also assessed. 
7.10.2. 24 Week Visit 
Patients will complete additional follow-up visits at 24 weeks for continued 
monitoring of the safety and efficacy of the therapy. All programming data will be 
captured on the appropriate case report form. 
A map of paresthesia coverage is collected along with final programming 
parameters, lead impedance, and device data.  Any changes in medications will be 
recorded. 
Pain metrics to be collected are patient-reported pain relief, NRS, and SF-MPQ.  
Quality of Life (EQ-5D) will also be assessed. 
7.10.3. Unscheduled Visit 
An Unscheduled Visit form will be used if a patient makes an unscheduled office 
visit. The Healthcare Utilization (HCOR) form will be completed for all 
unscheduled visits. 
The primary reason for the visit determines the need for additional information. In 
the event of a device malfunction, the changes in device will be captured on the 
Product Out of Service form. In the event of an adverse event, the investigator 
should complete the Adverse Event form. If the patient needs to be reprogrammed, 
the Paresthesia Location and Programming forms. If a revision or replacement is 
required, then the Additional Surgery and Product Out of Service forms will be 
completed.  
7.11. Outcome Measures  
7.11.1. Characterization of Procedure Time 
Procedure time will be characterized along the following metrics 
- 
Total operating room time (from prep to recovery) 
- 
Skin-to-skin surgery time (from first incision to last suture) 
- 
Programming time (time while delivering test stimulation to address proper 
lead placement) 
- 
Fluoroscopy time 
 

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7.11.2. Adverse Events 
Adverse events will be collected according to the section below.  Outcomes will be 
in percentage of patients experiencing events and total number of events, and will 
be stratified by severity, type, and resolution.  
7.11.3. Coverage 
As described below, paresthesia coverage of painful regions will be measured by 
comparing pain maps to paresthesia maps.  Adequate coverage of painful regions 
with paresthesia and avoidance of paresthesia outside of painful regions will be 
assessed. 
7.12. Additional Data 
The Study Coordinator or designee will give the patient the questionnaires to 
complete on his or her own. It is important that the patient understands the 
meaning of all the words in the questionnaires. The patient should be instructed to 
ask any questions about the questionnaires if further explanation is needed. Once 
the patient has completed the questionnaire, the Study Coordinator or designee 
will review the questionnaire for completeness to verify that all questions have 
been answered and only one response is chosen for each item.  
Short-Form McGill Pain Questionnaire (SF-MPQ-2) (Dworkin et al., 2009) 
The Short-Form McGill Pain Questionnaire version 2 (SF-MPQ-2) is a widely 
used scale used to measure the major symptoms of both neuropathic and non-
neuropathic pain. The self-administered questionnaire consists of a set of 22 
different pain descriptors. The patient is instructed to indicate how accurately the 
applicable the descriptor word describes their pain on a scale ranging from 0 
(‘None’) to 10 (‘Worst Possible’). The questionnaire takes approximately 5-10 
minutes to complete. There are a total of 3 sensory subscales (continuous pain 
descriptors, intermittent pain descriptors, and predominantly neuropathic pain 
descriptors) and 1 affective subscale scores. The total SF-MPQ-2 score is the sum 
of the four subscale scores. Higher scores indicate a higher severity of symptoms.  
Pain Evaluation Form  
Patients will be provided with a questionnaire to complete at follow-up visits.  
Patients will evaluate their pain relief from the device and rate their current, 
average, worst, and least pain. 
EuroQol (EQ-5D) generic health index questionnaire (Hurst, Kind, & Ruta, 1997) 
EQ-5D is a standardized instrument for measuring health outcome.  Applicable to 
a wide range of health conditions and treatments, it provides a simple descriptive 
profiles and single index value for health status.  The EQ-5D has standard layout 
for the five-dimensional (mobility, self-care, usual activities, pain/discomfort, 
anxiety/depression) descriptive system for recording an individual’s current EQ-
5D self-reported health state. Each of the five dimensions will be answered by one 
of five responses of increasing severity (no problems/slight problems/moderate 
problems/severe problems/unable or extreme) within a particular EQ-5D 
dimension.   
 

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Pain Location Form  
The Pain Location Form includes a map of the body that is labeled with different 
numbered regions. The patient is instructed to shade in or place an X in the area 
the patient is feeling pain.  
 
Paresthesia Coverage Form 
The Paresthesia Coverage Form includes a map of the body that is labeled with 
different numbered regions. The patient is instructed to shade in or place an X the 
area the patient is feeling stimulation/paresthesia. Patients will also indicate which 
area(s) of pain relief has given them the greatest improvement over their daily 
activities. This form looks similar to the Pain Location Form so it should be made 
clear to the patient that one is for pain and one is for paresthesia. 
8. Adverse Events (AEs)  
Adverse events are solicited at every study visit throughout the duration of the study. Adverse 
events will also be solicited at any unscheduled visits that occur.  
8.1. 
AE Definitions 
An ADVERSE EVENT is “Any change, undesired, noxious or pathological in a patient or 
patient illustrated by signs, symptoms and /or laboratory changes that occur during a  
clinical study, whether or not considered drug/treatment related.” 
A SERIOUS ADVERSE EVENT (SAE) is where the event is/causes: 
• Life threatening or fatal 
• Requires hospitalization ≥ 24 hours or prolongs an existing hospitalization 
• The patient to be disabled 
• Congenital anomaly or birth defect 
A NON-SERIOUS ADVERSE EVENT is an event other than one described above. 
A DEVICE-RELATED ADVERSE EVENT is an event where the Investigator feels that 
the device (i.e. IPG, lead, external device) contributed in any way to the adverse event 
occurring. 
A PROCEDURE-RELATED ADVERSE EVENT is one that the Investigator feels that 
the implant procedure (i.e. permanent or revision) contributed in any way to the adverse 
event occurring within 30 days post-procedure. 
As defined in 21 CFR §812.3 an UNANTICIPATED ADVERSE DEVICE EFFECT 
(UADE) is “any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
patients.”  An adverse device event that is not listed in Section 8.4 or included in the 
labeling for the device could potentially be classified as a UADE. If an UADE occurs, the 
investigator must notify St. Jude Medical Technical Services immediately, but no later 
than 10 working days after the investigator first learns of the effect, or in accordance with 
IRB policies.  

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A LIFE-THREATENING ADVERSE EVENT is one that places the patient, in the view of the 
initial reporter, at immediate risk of death from the adverse event as it occurred, i.e., it does not 
include an event that, had it occurred in a more severe form, might have caused death. 
DISABILITY is defined as a substantial disruption of a person's ability to conduct normal life 
functions, as assessed by the patient and the Investigator. 
A TREATMENT EMERGENT ADVERSE EVENT includes an event that was not present during 
the Baseline Evaluation and that occurred or worsened during treatment. 
8.2. 
AE Recording 
All device and/or procedure-related Adverse Events volunteered by the patients or elicited 
by the Investigator must be recorded on the AE forms provided. All serious AEs must be 
recorded whether or not considered device or procedure- related.  
8.3. 
Reporting AEs 
Throughout the course of the proposed study, all device and/or procedure-related adverse 
events will be recorded and monitored by the Investigator(s) at each participating site. 
Additionally, any serious adverse events observed by the investigator or reported by the 
patients, whether or not ascribed to the device or procedure will be recorded. Non-
device/procedure-related adverse events including but not limited to common cold, other 
bodily pain (such as dental or neck pain) or elective outpatient surgery with 
hospitalization less than 24 hours will not be recorded.  
Only adverse events that occur during or after system implantation will be collected. 
Every effort will be made to remain alert to possible adverse experiences and unexpected 
findings. If adverse experiences occur, the first concern will be the safety of the patient 
and appropriate medical intervention will be made.  
Individual reports of device and/or procedure-related adverse events and all serious 
adverse events should be documented and reported appropriately on the adverse event 
case report form. An investigator shall submit to the IRB a report of any unanticipated 
adverse effect (UADE) occurring during the investigation as soon as possible, in 
accordance with IRB policies.  
The Investigator must report all SAEs (e.g. unanticipated death or serious injury require 
hospitalization greater than 24 hours) to the IRB as soon as possible, in accordance with 
IRB policies. This notification can occur by email, telephone, or fax and the site will 
forward the completed AE form as soon as it is available.  
The Investigator must also promptly report the resolution to all reported serious, 
unanticipated, or device/procedure-related AEs. Non-serious adverse events should be 
reported at the next routine contact.  
All AEs shall also be reported to SJM and reviewed on a monthly basis. All SAEs will be 
submitted to the FDA by SJM immediately upon receipt. All AEs will be reviewed on a 
quarterly basis by SJM per their own standard operating procedures.  
 
8.4. 
 Anticipated Adverse Events and Complications 
Complications and anticipated adverse effects associated with SCS implantation include 
but are not limited to: 
• Stimulation at high outputs may cause unpleasant sensations or motor 

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disturbances, including involuntary movement. If either occurs, turn off your IPG 
immediately. 
• Undesirable changes in stimulation may occur over time. These changes may be 
related to cellular changes in tissue around the electrodes, changes in electrode 
position, loose electrical connections, and/or lead failure. 
• Stimulation may occur in unwanted places, such as the radicular (nerve root) chest 
wall area 
• A lead can move and result in changes in stimulation and/or a reduction in pain 
relief 
• Placement of a lead in the epidural space may cause epidural hemorrhage, 
hematoma, infection, spinal cord compression, and/or paralysis 
• Cerebrospinal fluid (CSF) leakage is possible 
• Paralysis, weakness, clumsiness, numbness, and/or pain below the level of the 
implant can occur 
• Persistent pain may occur at the electrode or IPG site 
• Seroma (mass or swelling) may occur at the IPG site 
• Implant materials may cause an allergic or rejection response 
• The implant can move, or skin can erode from around it 
• Battery failure and/or battery leakage is possible 
 
IPG Complications 
Changes in stimulation parameters may occur due to the failure of, or changes in, 
components over time, which results in: 
• Understimulation 
• Return of underlying symptoms 
• Overstimulation 
• Premature battery depletion, and 
• The need to explant the device 
8.5. 
 AE Classification 
The Investigator will classify each adverse event. If the adverse event is serious or the 
Investigator feels that the device contributed in any way to the adverse event, the 
Investigator must report the event to the IRB. 
8.5.1. Severity Rating  
The Investigator will use the following definitions to assess the severity of the 
adverse event to the device/procedure:  
A MILD adverse event is an event that causes awareness of signs or symptoms, 
but easily tolerated; are of minor irritant type; causing no loss of time from normal 
activities; symptoms would not require medication or a medical evaluation; signs 
and symptoms are transient. 

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A MODERATE adverse event is an event that causes discomfort severe enough to 
cause interference with usual activities; persistent or requiring treatment. 
A SEVERE adverse event is an event severe enough that causes an inability to 
perform normal, daily activities; persistent or requiring treatment. 
8.5.2.  Relationship to Device/Procedure 
An adverse event where the causal relationship to the device and/or procedure has 
been classified as possibly, probably, or definitely, the relationship must meet the 
NIH definition for relatedness of an adverse event to an intervention as follows: 
• 
Possibly Device/Procedure-Related:  (must meet at least 2 criteria) 
1) Has a reasonable temporal relationship to intervention, 
2) Could not readily have been produced by the patient’s clinical state, 
3) Could not readily have been due to environment or other interventions, 
4) Follows a known pattern of response to intervention. 
• 
Probably Device/Procedure -Related: (must meet at least 3 criteria) 
1) Has reasonable temporal relationship to intervention, 
2) Could not readily have been produced by the patient’s clinical state or have been 
due to environmental or other interventions, 
3) Follows a known pattern of response to intervention, 
4) Disappears or decreases with reduction in dose or cessation of intervention. 
• 
Definitely Device/Procedure -Related: (must meet all 4 criteria) 
1) Has a reasonable temporal relationship to intervention, 
2) Could not readily have been produced by the patient’s clinical state or have been 
due to environmental or other interventions, 
3) Follows a known pattern of response to intervention, 
4) Disappears or decreases with reduction in dose or cessation of interventional and 
recurs with re-exposure. 
9. Data Review and Database Management 
9.1. 
Site Monitoring 
Before study initiation at any sub-sites, the sponsor-investigator, or designee, will review 
the protocol and CRFs with the investigators and their staff, and protocol training will be 
documented 
The investigator must maintain source documents for each patient in the study, consisting 
of case and visit notes (hospital or clinic medical records) containing demographic and 
medical information, laboratory data, and the results of any other tests or assessments. All 
information on CRFs must be traceable to these source documents in the patient's file. 
Data not requiring a separate written record will be defined before study start and will be 
recorded directly on the CRFs. The investigator must also keep the original informed 
consent form signed by the patient (a signed copy is given to the patient). 
SJM will monitor all sites according to their own internal standard operating procedures.  
No information in source documents about the identity of the patients will be disclosed. 
9.2. 
Data Collection 
Designated investigator staff must enter the information required by the protocol onto the 
paper CRFs, and copies of the patient questionnaires will be sent to SJM. SJM will send a 

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monthly enrollment and CRF report to all investigators.  
9.3. 
Database Management and Quality Control 
Data from the patient questionnaires and CRFs will be reviewed by SJM following their 
own internal standard operating procedures. 
Errors or omissions on paper CRFs will generate queries that will be returned to the 
investigational site for resolution. Quality control audits will be completed by SJM as 
needed, and prior to finalizing data. 
SJM will send an updated database of all data on a quarterly basis unless the enrollment 
accelerates, in which case, SJM will send an updated database with the monthly 
enrollment/CRF report.  
10. Data Analysis  
10.1. Statistical Plan 
The study design for this investigation is a post-market, prospective, multicenter, parallel 
design,  non-blinded study with primary analysis at 24 weeks.  The primary objective in 
this study is to demonstrate the effectiveness and safety of the non-awake procedure 
compared to the awake procedure. 
10.2. Sample Size Justification 
Recent, retrospective studies of single center experience with the two procedures suggests 
the following complication and repositioning rates and procedure time (Falowski et al., 
2011; Shils & Arle, 2012):; 
 
Table 2:  Outcome rates for sample size calculation 
 
Non-awake 
Awake 
Revisions for device failure 
15% 
30% 
Lead repositioning for 
efficacy 
1% 
15% 
Infection rate 
4.5% 
6.0% 
Procedure time 
60 minutes 
90 minutes 
 
Simulations based on these results indicated that the sample size required to reject the null 
hypothesis at the 5% significance level is a minimum of 50 patients, who will be enrolled 
1:1 between the two procedures. Note that because neither procedure is currently 
considered the “gold standard”, and given the primary research objective of assessing 
safety and efficacy, it was determined that the sample size calculation should not be based 
on a formal hypothesis of non-inferiority with a pre-determined non-inferiority margin. 
Sample Size Adjustments - Patients have already been approved for a permanent system 
implant, thus a screen failure rate of 0% is assumed. The objective of the study is to study 
the implant procedures, eliminating the need to account for non-responders to treatment. 

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10.3. Primary Analysis 
10.3.1. Procedure Time 
Hypothesis: 
The non-awake method is faster than the awake method. 
Metrics:  
Skin-to-skin surgical time 
Intraoperative programming time 
Total fluoroscopy used (time and dose) 
 
Statistical Tests: 
Test for normality (such as Jarque-Bera) 
Unpaired, two-sided Student’s t-tests (normally distributed continuous data) or Mann-
Whitney rank sums test (skewed continuous data) 
Significance at α < 0.05, with no adjustment for the multiple comparisons 
 
10.3.2. Number of adverse events 
Hypothesis: 
The non-awake is comparable to the awake method in the number of adverse events. 
Metrics:  
Rate of adverse events (percentage of patients with an adverse event) 
Statistical Tests: 
Chi-square or Fisher’s exact test as appropriate based on the number of adverse events 
Significance at α < 0.05, with no adjustment for the multiple comparisons 
 
10.3.3. Procedure Time 
Hypothesis: 
The non-awake is comparable to the awake method in the number of revisions 
Metrics:  
Rate of revisions (percentage of patients with a revision) 
Statistical Tests: 
Chi-square or Fisher’s exact test as appropriate based on the number of adverse events 
Significance at α < 0.05, with no adjustment for the multiple comparisons. 
 
10.4. Secondary Analysis 
10.4.1. Paresthesia coverage 
Hypothesis: 
The non-awake is comparable to the awake method in the proportion of the painful 
regions covered by paresthesia 
Metrics: 
Paresthesia overlap percentage 

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Extraneous paresthesia percentage 
The regions marked on the Pain Location Form and Paresthesia Coverage form will be 
categorized as overlapping, uncovered pain, excess paresthesia, or none (see  
Table 3; Alo, Yland, Redko, Feler, & Naumann, 1999). 
 
𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑒𝑒𝑒𝑒 𝑜𝑜𝑜𝑜𝑜𝑜𝑜 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝= 
𝑁𝑂
𝑁𝑈+𝑁𝑂 ̇100  
 
𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒𝑒 𝑝𝑝𝑝𝑝𝑝𝑝ℎ𝑒𝑒𝑒𝑒 𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝𝑝= 
𝑁𝐸
𝑁𝑂+𝑁𝐸 ̇100  
 
Statistical Tests: 
Test for normality (such as Jarque-Bera) 
Unpaired, two-sided Student’s t-tests (normally distributed continuous data) or Mann-
Whitney rank sums test (skewed continuous data) 
Significance at α < 0.05, with no adjustment for the multiple comparisons 
 
 
 
 
 
 
 
 
 
 
Table 3: Pain-Paresthesia Comparison Categories 
 
10.5. Additional Analysis 
Summary statistics will be calculated for additional data.  Post-hoc analysis may be done 
based on findings. 
10.6. Data Sets 
All patients who complete the 6 week follow-up appointment and questionnaires will be 
included in the analysis.   
Patients with missing baseline values will be excluded from the analysis. Missing data 
pertaining to adverse events will not be imputed.  
11. Withdrawal of Patients from Study 
Withdrawal is defined as a patient’s termination of participation from a clinical study. Patients 
may be discontinued from the study at any time. The reason for discontinuation will be recorded 
 
Paresthesia Coverage Form 
Marked 
Unmarked 
Pain Location Form 
Marked 
Overlap 
𝑁𝑂  
Uncovered 
𝑁𝑈  
Blank 
Excess 
𝑁𝐸  
None 
𝑁𝑁  

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on the Exit and Withdrawal form. Discontinued patients may not be replaced in the study. Prior to 
discontinuing a patient, every effort should be made to contact the patient in an effort either to get 
the patient back into compliance with the protocol, or to obtain as much follow-up data as 
possible. Reasons for discontinuation include, but are not necessarily limited to: 
• 
Voluntary withdrawal by the patient; 
• 
Patient is Lost to Follow-up: Patient will be considered “lost to follow-up” after a minimum of 2 
documented phone calls by personnel at the investigational center to the patient or emergency contact 
and a certified letter was sent to the last known address.  
• 
Investigator may discontinue the patient’s participation in the study for reasons including but not 
limited to: patient noncompliance, surgical revision not appropriate, unwillingness or inability to 
cooperate with study requirements (therapy regimen, follow-up visits, etc.). 
12. Modification of Protocol 
Any amendments to this protocol must be prepared by the Coordinating Investigator and 
approved by the appropriate regulatory agencies and the local authority (IRB) before 
implementation by the Investigator. 
13. Discontinuation of Study 
The Clinical Coordinating Investigator reserves the right to discontinue any study at any time for 
administrative reasons, such as but not limited to, a decision to discontinue further clinical 
Investigations with the devices, improper conduct of the study by the Investigator, inability to 
obtain the number of patients required by the protocol, etc.  
If the study is prematurely terminated or suspended, it is the responsibility of the investigator to 
promptly inform the patients and assure appropriate therapy and follow-up. The Investigator must 
also adhere to local IRB requirements and reporting of study termination or discontinuation.  
 
 
 

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14. References  
Air, E. L., Toczyl, G. R., & Mandybur, G. T. (2012). Electrophysiologic Monitoring for Placement of 
Laminectomy Leads for Spinal Cord Stimulation Under General Anesthesia. Neuromodulation: 
Technology at the Neural Interface, 15(6), 573–580. doi:10.1111/j.1525-1403.2012.00475.x 
Alo, K. M., Yland, M. J., Redko, V., Feler, C., & Naumann, C. (1999). Lumbar and Sacral Nerve 
Root Stimulation (NRS) in the Treatment of Chronic Pain: A Novel Anatomic Approach and 
Neuro Stimulation Technique. Neuromodulation : journal of the International Neuromodulation 
Society, 2(1), 23–31. doi:10.1046/j.1525-1403.1999.00023.x 
Burchiel, K. J., Anderson, V. C., Brown, F. D., Fessler, R. G., Friedman, W. A., Pelofsky, S., … 
Shatin, D. (1996). Prospective, multicenter study of spinal cord stimulation for relief of chronic 
back and extremity pain. Spine, 21(23), 2786–94. 
Cameron, T. (2004). Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: 
a 20-year literature review. Journal of neurosurgery, 100(3 Suppl Spine), 254–67. 
Dworkin, R. H., Turk, D. C., Revicki, D. a, Harding, G., Coyne, K. S., Peirce-Sandner, S., … 
Melzack, R. (2009). Development and initial validation of an expanded and revised version of 
the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain, 144(1-2), 35–42. 
doi:10.1016/j.pain.2009.02.007 
Falowski, S. M., Celii, A., Sestokas, A. K., Schwartz, D. M., Matsumoto, C., & Sharan, A. (2011). 
Awake vs. asleep placement of spinal cord stimulators: a cohort analysis of complications 
associated with placement. Neuromodulation : journal of the International Neuromodulation 
Society, 14(2), 130–4; discussion 134–5. doi:10.1111/j.1525-1403.2010.00319.x 
Hurst, N., Kind, P., & Ruta, D. (1997). Measuring health-related quality of life in rheumatoid 
arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Rheumatology, 551–559. 
Kemler, M. A., de Vet, H. C. W., Barendse, G. A. M., van den Wildenberg, F. A. J. M., & van Kleef, 
M. (2008). Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: 
five-year final follow-up of patients in a randomized controlled trial. Journal of neurosurgery, 
108(2), 292–8. doi:10.3171/JNS/2008/108/2/0292 
Khan, Y. N., Raza, S. S., & Khan, E. a. (2005). Application of spinal cord stimulation for the 
treatment of abdominal visceral pain syndromes: case reports. Neuromodulation : journal of the 
International Neuromodulation Society, 8(1), 14–27. doi:10.1111/j.1094-7159.2005.05216.x 
Shils, J. L., & Arle, J. E. (2012). Intraoperative Neurophysiologic Methods for Spinal Cord 
Stimulator Placement Under General Anesthesia. Neuromodulation: Technology at the Neural 
Interface, 15(6), 560–572. doi:10.1111/j.1525-1403.2012.00460.x 
Turner, J. A., Loeser, J. D., Deyo, R. A., & Sanders, S. B. (2004). Spinal cord stimulation for patients 
with failed back surgery syndrome or complex regional pain syndrome: a systematic review of 
effectiveness and complications. Pain, 108(1-2), 137–47. doi:10.1016/j.pain.2003.12.016 

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15. Appendix A: Case Report Form Matrix 
 
Case Report Form 
Screening 
Baseline 
Perm 
Implant 
Surgery 
Initial 
Programmin
g 
6 Weeks 
24 Weeks 
Unscheduled 
Visits  
Enrollment 
x 
  
  
  
  
  
  
Inclusion/Exclusion  
 x 
 
  
  
  
  
  
Baseline Self 
Evaluation  
 
x 
 
 
 
 
 
Pain Location  
 
x  
  
  
 x 
x  
  
Pain Evaluation 
  
x 
  
  
x 
x 
 
Medication  
  
x 
x 
x 
x 
x 
x 
SF-MPQ-2 
  
x 
  
  
x 
x 
  
EQ-5D 5L 
  
x 
  
  
x 
 x 
  
Surgery  
  
  
x 
  
  
  
  
Programming  
  
  
  
x  
x 
x 
x 
Paresthesia Coverage  
  
  
  
x 
x 
x 
x 
Patient Global 
Impression 
 
 
 
x 
 
 
 
Follow-Up Visit 
 
 
 
x 
x 
x 
x 
Unscheduled Visit 
 
 
 
 
 
 
x 
HCOR form 
 
 
 
 
 
 
x 
Deviation  
TO BE COMPLETED AS NEEDED 
 
Additional Surgery  
Product Out of Service  
Adverse Event 
Exit and Withdrawal  
 
 
 
 

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16. Appendix B: Patient Questionnaires  
 
The following questionnaires will be completed by the patient: 
 
o Baseline Self Evaluation Form 
 
o Patient Global Impression Form 
 
o SF-MPQ-2 
 
o Pain Evaluation Form 
 
 
[IN FINAL PDF VERSION APPEND CRF PDFs]