Clinical trial NCT02090998
Conditions: Transformed Migraine Chronic Daily Headache
Keywords: Migraine Headache Menstrual Migraine Vascular Headache Temporal Lobe Seizure
Sponsor: Rutgers, The State University of New Jersey
Start date: 2014-05-01; Completion date: 2020-03-16
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.

Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.

We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects

Detailed description:
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Arms: arm 1: Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated arm 2: Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
Interventions: intervention 1: SPG Block with 5% Lidocaine gel intervention 2: Amitriptyline
Intervention descriptions: intervention 1: cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia intervention 2: The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days

Protocol documents:
Prot_SAP_000.pdf: 
Statistical Analysis Plan 
 
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INTERVENTIONAL 
RESEARCH PROTOCOL TEMPLATE 
(HRP-503a) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan 
 
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Statistical Analysis Plan 
 
TRIAL FULL TITLE 
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of 
Transformed Migraines 
SAP VERSION 
1 
SAP VERSION DATE 
8/3/2021 
TRIAL STATISTICIAN 
William R. Grubb, MD 
Protocol Version (SAP 
associated with) 
Version 1 Protocol 2012002610 
TRIAL PRINCIPAL 
INVESTIGATOR 
William R. Grubb, MD 
SAP AUTHOR(s) 
William R. Grubb, MD 
1 
SAP Signatures 
I give my approval for the attached SAP Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment 
of Transformed Migraines dated 8/3/2021 
Statistician (Author) 
Name: William R. Grubb, MD 
Signature: 
   
             
Date: 
 
    8/3/2021                            
Statistician Reviewer (As applicable) 
Name: William R. Grubb, MD 
Signature: 
  
             
Date: 
 
   8/3/2021                                              
Principal Investigator 
Name: William R. Grubb, MD 
Signature: 
  
                 
Date: 
 
    8/3/2021                             
 
 


Statistical Analysis Plan 
 
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Table of Contents  
Skip To Section: Hold CTRL + Click (Below) To Follow Link in Blue 
 
1.0 
Research Introduction 
 
 
1.1 
Purpose/Specific Aims 
 
 
1.2 
Research Significance 
 
 
1.3 
Research Design and Methods 
 
 
1.4 
Preliminary Data 
 
 
1.5 
Sample Size Justification 
 
 
1.6 
Study Variables 
 
 
1.7 
Drugs/Devices/Biologics 
 
 
1.8 
Primary Specimen Collection 
 
 
1.9 
Interviews, Focus Groups, or Surveys 
 
 
1.10 
Timetable/Schedule of Events 
 
 
2.0 
Project Management 
 
 
2.1 
Research Staff and Qualifications 
 
 
2.2 
Resources Available 
 
 
2.3 
Research Sites 
 
 
3.0 
Multi-Site Research Communication & Coordination 
 
 
3.1 
Outside Research 
 
 
4.0 
Research Data Source/s 
 
 
4.1 
Primary Data – Subjects and Specimens 
 
 
4.2 
Subject Selection and Enrollment Considerations 
 
 
4.3 
Subject Randomization 
 
 
4.4 
Secondary Subjects 
 
 
4.5 
Number of Subjects 
 
 
4.6 
Consent Procedures 
 
 
4.7 
Special Consent Populations 
 
 
4.8 
Economic Burden and/or Compensation For Subjects 
 
 
4.9 
Risks to Subjects 
 


Statistical Analysis Plan 
 
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4.10 
Secondary Data – Record/Chart Reviews, Databases, Tissue Banks, Etc. 
 
 
4.11 
Chart/Record Review Selection 
 
 
4.12 
Secondary Specimen Collection 
 
 
5.0 
Special Considerations 
 
 
5.1 
Health Insurance Portability and Accountability Act (HIPAA) 
 
 
5.2 
Family Educational Rights and Privacy Act (FERPA) 
 
 
5.3 
NJ Access to Medical Research Act 
 
 
5.4 
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
 
6.0 
Research Data Protection and Reporting 
 
 
6.1 
Data Management and Confidentiality 
 
 
6.2 
Data Security 
 
 
6.3 
Data Safety And Monitoring 
 
 
6.4 
Reporting Results 
 
 
6.5 
Data Sharing 
 
 
7.0 
Data and/or Specimen Banking 
 
 
8.0 
Other Approvals/Authorizations 
 
 
9.0 
Bibliography 
 
 
1.0 Research Introduction 
1.1 Purpose/Specific Aims 
Ø Purpose of study 
The purpose of this study is to compare a local anesthetic technique (sphenopalatine ganglion block) versus 
medical management with the traditional antidepressant Elavil for the treatment of patients suffering from 
transformed migraines (chronic migraines). 
Ø Objectives 
The objective is to randomize subjects who present with transformed migraine headaches into one of two 
treatment groups to compare the efficacy of the therapies. Subjects will receive either a sphenopalatine ganglion 
block with 5% lidocaine ointment into the nasopharynx or medical management with the traditional 
antidepressant, Elavil, to produce a reduction in the frequency and severity of the headache.  
Ø  Hypotheses 
We propose that there will be a difference in the outcomes when comparing the two methods of treating 
transformed migraines and that one research arm will result in higher satisfaction and greater efficacy in the 
treatment of subjects. 
Transformed migraines, also known as chronic migraines, is an illness that initially presents as episodic migraine 
headaches whose frequency increases in a matter of months to years. These episodic migraines transform to 
chronic migraines that occur every day. Accompanying the migraines can be symptoms such as photophobia, 


Statistical Analysis Plan 
 
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phonophobia, nausea, and gastrointestinal distress. Preventative therapy for transformed migraines revolves 
around pain management and antidepressant use (8). 
Patients who suffer from chronic headaches have been treated with a variety of nerve blocks for immediate relief. 
Among those nerve block treatments has been the sphenopalatine ganglion block. 
 The sphenopalatine ganglion lies posterior to the middle turbinate and maxillary sinus, anterior to the medial 
plate of the pterygoid process, and inferior to the sphenoid sinus and maxillary nerve. It has been reported that its 
sensory function is to innervate the nasal cavity linings, throat, and sinuses (1).  
Nerve blocks have a role in headache therapies and have been noted to be effective in those headaches produced 
by the complication of post dural puncture headache after spinal or inadvertent epidural block. Furthermore, 
nerve blocks have been used for the treatment of cluster headaches (7). Hardebo and Elner report aborting cluster 
headaches with the use of sphenopalatine ganglion block (5). Our recent review of the literature has also 
suggested that there is a vast variety in the methods of administration of the block, as well as a lack of support for 
its benefit in patients suffering from transformed migraines. A proven method of performing the block uses a 
cotton tip applicator to place lidocaine gel 5% in the middle posterior pharynx. This technique of allowing for 
transmucosal application of local anesthetics was proposed by Lebovits (6) and modified by Chan-Liao (2).  
Pharmacotherapy has also been useful in the treatment of headaches. Patients who suffer from chronic migraine 
headaches who have been treated with antidepressant therapy report success. The traditional antidepressant 
Elavil, also known as amitriptyline, has been reported to be an effective antimigraine agent (3) and is one of the 
first-choice drugs used for migraine prophylaxis (4).  
1.2 Research Significance 
 
The sphenopalatine ganglion has been identified in the literature as a potential target for the 
management of headaches. There are many reports of the use of the sphenopalatine block as a treatment for 
acute headaches, but there have been no prospective studies that evaluate the efficacy of the therapy for chronic 
headache therapy of the transformed type. 
1.3 Research Design and Methods  
The design of the study consists of the randomization of subjects suffering from transformative migraine headache 
in one of two groups.  The study is not blinded; as the participants will know which method they are being treated 
with because of the difference in site and nature of the nerve blocks. The randomization will be created and will 
assign 26 subjects into one of two groups to receive:  
Group 1 – Will receive 5% lidocaine ointment to the mucosa overlying the sphenopalatine ganglion in the 
nasopharynx. During placement of the intranasal ointment the subjects will be monitored for standard parameters 
including blood pressure, heart rate, and pulse oximetry. 
Group 2 – Will receive medical management with Elavil 10 mg PO qday x 1 week then 20 mg PO qday x 3 weeks. 
Subjects will be seen weekly for four weeks and a fifth and final visit will take place approximately two to four 
weeks after the fourth visit. Safety and the assessment of adverse events will be conducted throughout the study. 
At the beginning of each week, a 7-day calendar-formatted questionnaire will be distributed to the subjects (See 
Appendix A). Subjects will be asked to fill out the questionnaire each day for that week. This questionnaire will 
include the following parameters: number of daily headaches within the last 24 hours, length of the duration of 
the headache, duration of inactivity associated with the headache, intensity of the headache (0=no headache, 
10=worst headache ever), epistaxis, nausea, or vomiting present. The subjects that are in the group receiving the 
5% lidocaine will also be asked to fill out a questionnaire 20 minutes after receiving the sphenopalatine ganglion 
block (See Appendix B). This questionnaire will include the following: Did the SPG block relieve the headache after 


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the 20 minutes. All subjects will also be asked to fill out a questionnaire during their post-therapy check-up (1 
week following the first day of therapy) (See Appendix C). This questionnaire will include the following parameters: 
Did you modify your usual customary therapy as a result of our therapy, satisfaction with treatment 1-10 (0=not 
satisfied, 10=extremely satisfied). Copies of the questionnaires can be found in Appendix A, B, and C. 
1.4 Preliminary Data 
N/A 
 
1.5 Sample Size Justification 
This is a randomized, unblinded prospective study comparing two different treatments in parallel.  The total 
sample size will be 26 patients based on power analysis; thus, each treatment group will have 13 randomized 
subjects. Sample size calculations were performed for an independent sample t-test using a power level of 95% at 
5% significance level. Since no pilot study has ever been published comparing these treatment modalities, a mu1 
value of 4 and mu2 value of 6 with a sigma value of 2 were used for power analysis. 
1.6 Study Variables 
 
A. Independent Variables, Interventions, or Predictor Variables  
Sphenopalatine Ganglion Block 
Elavil  
 
B. Dependent Variables or Outcome Measures  
Headache Intensity 
Number of daily headaches 
Duration of headaches 
Duration of inactivity associated with headaches 
Epistaxis 
Nausea 
Vomiting 
Patient Satisfaction 
 
1.7 Drugs/Devices/Biologics 
 
The study involves the use of 2mL / 5% lidocaine gel which is dispensed as a single use item for each patient. 
The drug will be applied via a hollow cotton tip applicator 2mL of 1% lidocaine. 
The study involves the use of Elavil which is prescribed via pharmacy. 
 
1.8 Primary Specimen Collection 
N/A 
 
1.9 Interviews, Focus Groups, or Surveys  
N/A 
 
1.10 Timetable/Schedule of Events 
N/A 
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications 
The study will be conducted by William Grubb MD, DDS, an Interventional Pain Management specialist and Board-
Certified Anesthesiologist who has many years of experience in the treatment of chronic facial pain and headache 


Statistical Analysis Plan 
 
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refractory to triptins and beta blockers. The sub-I, Brian Gerhardstein, DM, is a board-certified Neurologist with a 
special clinical interest in headaches. He has been medically managing patients with headaches for over a decade. 
  
2.2 Resources Available 
Facilities: Our research will be conducted entirely within the Anesthesiology Pain Clinic offices in the RWJ Clinical 
Academic Building. These clinical offices are used for outpatient clinical services and follow-up. 
Medical or Psychological resources: There are no anticipated consequences as a result of this research and 
therefore special medical or psychological resources are unnecessary.  
Research Staff Training: The study will be conducted in its entirety by the PI (William Grubb, MD, DDS). The sub-I 
(Brian Gerhardstein, MD) will assist with data analysis and publication. 
2.3 Research Sites 
Our research will be conducted entirely within the Anesthesiology Pain Clinic offices in the RWJ Clinical Academic 
Building. 
 
3.0 Multi-Site Research Communication & Coordination  
 
3.1 Outside Research 
N/A 
 
4.0 Research Data Source/s 
 
4.1 Primary Data-Subjects and Specimens 
Primary data endpoints will include patient provided headache intensity scores, number of daily headaches, duration 
of headaches, duration of inactivity associated with headaches, incidence of epistaxis, incidence of nausea, incidence 
of vomiting and patient satisfaction scores. 
 
4.2 Subject Selection and Enrollment Considerations  
 
A. Recruitment Details 
Potential subjects will be identified and recruited by the PI (William Grubb, MD, DDS) during patient visits 
at the anesthesia pain management clinical services office.  
 
B. Source of Subjects 
Subjects presenting to our clinical services (anesthesia pain management) offices at RWJ. 
 
C. Method to Identify Potential Subjects 
During clinic visits, the PI will identify patients who present with transformative headaches despite having 
already received optimal medical management (including triptans and anticonvulsants). 
 
D. Subject Screening 
Individuals will be screened by and enrolled into the study by Dr. William Grubb. 
Inclusion Criteria: 
• 
Males and females ages 18-90 
• 
Subjects who have formal medical diagnosis of transformed migraine headache 
• 
Subjects who currently require treatment for migraine headache, but not receiving elavil 
• 
Subjects who have received optimal stable medical management for migraines for  3 
months, including triptans (Imitrex, Amerge, Relpax) , and pain medications including 
Motrin, Excedrin, Aspirin, or Fiorecet , or narcotic medications prescribed by your doctor   


Statistical Analysis Plan 
 
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• 
Subjects who have received not been responding to optimal medical management for 
migraines including triptans (Imitrex, Amerge , Relpex ) anticonvulsants (Depakote, Lamictal, 
Clonopin), and/or beta-blockers such as Inderal, or Catapres 
Exclusion Criteria: 
• 
Patients less than 18 years of age or older than 90 years of age 
• 
Subjects will be excluded if they are already being treated with lidocaine (patch or other 
vehicle) for chronic pain 
• 
Subjects who are unwilling to participate or Cognitively impaired patients 
• 
Non-English speaking patients  
• 
Untreated heart failure 
• 
Pregnancy (females between the age of 18-50 will have pregnancy testing prior to each 
intervention ) 
• 
Individuals unwilling to comply with study procedures and follow-up 
• 
Subjects who are allergic to Elavil or lidocaine 
• 
Medical history of hypersensitivity to local anesthetics, including lidocaine 
 
Subjects who are already being treated with lidocaine for chronic pain must be excluded due to cross mechanism 
of action of their ongoing treatment modality with one of the treatment arms (sphenopalatine ganglion block with 
5% lidocaine gel). Patients with cognitive disfunction must be excluded because our primary data endpoints rely on 
effective and precise patient feedback. Patient less than 18 years of age will be excluded from this study. There are 
two reasons for this. First, the patient population treated by the clinical investigators of this study are adults, not 
children. Second, it is not fully understood whether the pathophysiology of chronic or transformed migraines is the 
same in the pediatric population as that of the adult population. Non-English speaking patients must be excluded 
from this study as the term “headache” has markedly different interpretations across various languages and 
cultures. Patients who are pregnant or have untreated heart failure must be excluded due to contraindication. 
Finally, individuals unwilling to comply with study procedures and follow-up will be excluded in order to assure 
quality outcome data. 
 
E. Recruitment Materials 
N/A 
 
F. Lead Site Recruitment Methods 
N/A 
 
4.3 Subject Randomization 
 
The subjects will be assigned to a treatment arm using a randomly generated list. 
 
4.4 Secondary Subjects 
 
N/A 
 
4.5 Number of Subjects 
A. Total Number of Subjects 
26 
 
B. Total Number of Subjects If Multicenter Study 
N/A 
 
C. Require Number of Subjects to Complete Research 
26 
 


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D. Feasibility of Recruiting 
Recruiting is feasible as our anesthesia pain clinic offices treat patients with transformed migraine 
headaches. 
 
4.6 Consent Procedures 
A. Consent 
Documenting Consent 
The informed consent process will begin after a subject has been diagnosed and is presenting for 
consultation for transformed migraine. Each patient will be given the informed consent document to 
read and consider prior to agreeing to participate. The primary investigator will answer all the 
subjects’ questions and ensure the subject has adequate time to consider participation prior to 
signing the informed consent document. No study assessments, measurements or interventions will 
occur prior to subject signing the informed consent document.  
 In addition, at each encounter with the subject, the primary investigator will ask the subject if he / 
she is agreeable to continued study participation at the beginning of each visit. 
In addition, urine pregnancy tests will be performed for all females 18-50 years of age at each visit 
and prior to initiation of intervention.  
§ Waiver of Documentation of Consent 
N/A 
 
§ Waiver or Alteration of Consent Process 
N/A 
(i) Use of Deception/Concealment 
N/A 
 
B. Consent Process 
§ Location of Consent Process 
The written consent will be obtained after initial consult at the anesthesiology pain medicine 
clinic offices in the clinical academic building. 
 
§ Ongoing Consent 
Continued verbal consent will be obtained at each weekly visit. 
 
§ Individual Roles for Researchers Involved in Consent 
William Grubb, MD, DDS will be the sole individual responsible for identifying, enrolling and 
consenting patients for this study. 
1. Consent Discussion Duration 
At least 30 minutes will be dedicated to reviewing the consent with each patient. All 
patient questions will be addressed prior to the completion of the consent process. 
2. Coercion or Undue Influence 
Subjects will be reminded and reassured that they do not need to participate to 
receive continued treatment at the anesthesia pain management clinical offices. 
3. Subject Understanding 
Subjects will be given 1 week to review a copy of the protocol prior to being 
allowed to consent. 
 
4.7 Special Consent/Populations 
 
A. Minors-Subjects Who Are Not yet Adults  
§ Criteria for Consent of Minors 


Statistical Analysis Plan 
 
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N/A 
§ Wards of the State 
N/A 
1. Research in NJ Involving Minors 
N/A 
. 
2. Research Outside of NJ Involving Minors 
N/A 
Parental Permission 
N/A 
 
§ Non-Parental Permission 
N/A 
§ Assent Process 
N/A 
1. Documentation of Assent 
N/A 
. 
§ 
Non-English Speaking Subjects. 
1. Process for Non-English Speaking Subjects 
N/A 
§ 
Short Form Consent for Non-English Speakers 
N/A 
B. Adults Unable to Consent / Cognitively Impaired Adults (for interventional studies) 
§ 
NJ Law-Assessment of Regaining the Capacity To Consent 
N/A 
 
§ 
Capacity To Consent 
N/A 
§ 
NJ Law-Selecting A Witness 
N/A  
§ 
Removing a Subject 
N/A 
 
 
4.8 Economic Burden and/or Compensation for Subjects 
A. Expenses as a result 
There will be no economic burden or additional expenses as a result of participation in the research. 
  
B. Compensation/Incentives 
There be no compensation for participation in the research. 
  
4.9 Risks to Subjects 
 
A. Description of Subject Risk 
There are few risks known or associated with participation in the research. 
They are listed below. 
 
B. Procedures for Risks to Embryo, Fetus, and/or Pregnant Subjects 
The protocol will require pregnancy testing prior to each intervention. Female participants between  
ages of 18-50 and females will be advised to avoid becoming pregnant during the study. 
Any participant who becomes pregnant during the study will be withdrawn from continuation. 
 


Statistical Analysis Plan 
 
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C. Risks to Non-Subjects  
There are no predicted risks to non subjects. 
 
D. Assessment of Social Behavior Considerations 
Patients having agreed to the procedure and known to be actively treated for psychological issues 
will have the opportunity to discuss participation with their mental health professional.  
 
Reasonably Foreseeable Risks 
 Subjects may experience minor local discomfort during the SPGB procedure. 
1. Bitter taste in the back of the throat. 
2. Difficulty talking while procedure is taking place. 
3. Difficulty eating and drinking for a few minutes to up to 2 hours after the SPGB. 
4. May have blood tinged secretions from bilateral nares post procedure.   
5. Blood may be seen from the nares at the end of the procedure. 
 
There is always the potential for loss of anonymity with any clinical study; however, stringent safety measures will 
be in place to prevent any breeches in confidentiality. 
There are no known psychological/emotional, social, legal and economic risks of harm from the sphenopalatine 
ganglion block. 
E. Minimizing Risks 
Risks with this study are minimal. The potential for loss of anonymity will be minimized by keeping all 
patient information in a locked box in the anesthesia pain management clinical offices. William Grubb, 
MD, DDS will be the only individual with access to this locked box where all patient information will be 
stored. When the patient data is converted into electronic data for data analysis following the conclusion 
of patient data collection, all patient information will be encrypted. Patients will always be deidentified 
electronically when possible. 
F. Certificate of Confidentiality 
N/A 
G. Potential Benefits to Subjects 
1. 
General feeling of relaxation of the neck muscles during the SPGB 
2. 
Potential overall improvement in headaches 
3. 
Reduction in the total amount of medications required to achieve relief of headache  
pain 
4. 
Potential narcotic or barbituate sparing 
5. 
Improvement of overall quality of life 
6. 
Potential ability to prescribe SPGB for home use after subject is taught the technique by  the 
investigators 
H. Provisions to Protect the Privacy Interests of Subjects 
Patients will only provide personal information to William Grubb, MD, DDS. They will not be expected to 
interact with any other individual for the purposes of this study. 
I. Research Team Access to Subject Data 
William Grubb, MD, DDS will be the only research team member with access to the patient data. Patient 
data will be stored in a locked box in the anesthesia pain management clinical offices. Once data 
collection is complete after 26 patients have been enrolled, William Grubb, MD, DDS will convert the data 


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from paper to electronic format for subsequent data analysis. Patient information will be deidentified and 
all information will be encrypted.  
 
4.10 Secondary Data – Records/Chart Reviews/Databases/Tissue Banks/etc. 
N/A 
 
4.11 Chart/Record Review Selection 
N/A 
 
4.12 Secondary Specimen Collection 
N/A 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
N/A 
 
5.2 Family Educational Rights and Privacy Act (FERPA) 
N/A 
 
5.3 NJ Access to Medical Research Act 
N/A 
5.4 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
A. “Special" Classes Of Subjects 
(1) Pregnant Women: see guidance (HRP-412) - Reviewed 
(2) Neonates: see guidance (HRP-413) - Reviewed 
(3) Neonates of Uncertain Viability: see guidance (HRP-414) - Reviewed 
(4) Prisoners: see guidance (HRP-415) - Reviewed 
(5) Children: see guidance (HRP-416) - Reviewed 
(6) Cognitively Impaired Adults: see guidance (HRP-417) - Reviewed 
 
6.0 Research Data Protection and Reporting 
 
6.1 Data Management and Confidentiality 
A. Data analysis will occur using SPSS. The appropriate statistical test will be used to compare the various 
types of collected data including independent variable t-tests for primary data endpoint means. 
B. Power Analysis:  
Power analysis calculations were conducted using uA of 4, uB of 6, sigma or SD of 2, sampling ratio of 1, 
type I error rate of 0.05 and sample size of 26 yielding a power of 0.95. 
C. No individual will require training as only the PI, William Grubb, MD, DDS will have access to the stored 
patient data. William Grubb, MD, DDS will also be the only individual handling the data. A lock and key 
mechanism will be used for access to the patient data. This will be in addition to all building security 
control measures in the clinical academic building. During conversion of paper data to electronic data, 
patients will be deidentified. 
D. None 
E. Describe how data be handled study-wide: 
§ 
What information will be included in that data? The patient responses during clinic visits are the 
only data that will be collected and stored. 
§ 
Where, how, and for how long will the data will be stored? Anesthesia pain management clinical 
offices, 5th floor Clinical Academic Building. Locked box. Until 26 patients have been enrolled. 
§ 
Who will have access to the data? William Grubb, MD, DDS 
§ 
Who is responsible for receipt or transmission of the data? William Grubb, MD, DDS 


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§ 
How will the data will be transported/shared? It will not be transported or shared. 
 
6.2 Data Security 
Only William, Grubb, MD, DDS will have access to the data placed into storage for this clinical research trial. All 
data collection will be secure using a physical locked box. Only William Grubb, MD, DDS will have a key for the 
locked box. The locked box will always remain in the anesthesiology pain management clinical offices on the fifth 
floor of the clinical academic building, a building with a high degree of security. The link to the PHI will be stored 
separately from the study files and will be destroyed after all the data has been collected and analyzed. Once data 
collection is complete after 26 patients have been enrolled in this study, William Grubb, MD, DDS will convert 
paper data to electronic data. All information will be deidentified and encrypted when converted to electronic 
data. All data analysis will occur using SPSS software.  
 
6.3 Data and Safety Monitoring  
N/A. This study provides minimal risk. 
 
6.4 Reporting Results 
A. Sharing of Results with Subjects  
N/A. There will be no sharing of results with subjects. 
B. Individual Results  
N/A. There will be no sharing of results with subjects. 
C. Aggregate Results  
Aggregate results will be shared with all study participants pending data publication in a medical journal. 
All participants will be provided with a copy of the final conclusion of the study. 
D. Professional Reporting 
Pending data collection, analysis and interpretation, a manuscript will be written and published in an 
academic medical journal. 
E. ClinicalTrials.Gov Registration and Data Reporting – changes and updates to this study will be         
updated on ClinicalTrials.Gov after IRB approval 
NCT02090998 
 
6.5 Data Sharing   
N/A 
 
7.0 Data and/or Specimen Banking 
N/A 
 
8.0 Other Approvals/Authorizations 
N/A 
 
9.0 Bibliography 
1. Campbell EH. Anatomic studies of the sphenopalatine ganglion and the posterior palatine canal with 
special reference to the use of the latter as the injection Route of Choice. 
2. Chan-Liao M. On-line website: http://www.pain-manage.org.tw/s-pain-pain05.htm  
3. Couch JR, Hassanein RS. Amitriptyline in migraine prophylaxis. Arch Neurol 1979; 36(11):695-699. 
4. Evers, Stefan. Treatment of migraine with prophylactic drugs. Expert Opinion on Pharmacotherapy 2008; 
9(15): 2565-2573. 
5. Hardebo J, Elner A. Nerves and vessel in the pterygopalatine fossa and symptoms of cluster headaches. 
Headache 1987; 27:528-532 
6. Lebovits A, Howard A, Lefkowitz M. Sphenopalatine ganglion block: Clinical use in the pain management 
clinic. Clin J Pain 1990; 6: 131-136. 


Statistical Analysis Plan 
 
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines   
 
SAP version I: Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines Date of Version 8/3/2021 
 
Page 14 of 16 
7. Tepper SJ, Stillman MJ. Cluster Headache: Potential Options for Medically Refractory Patients (When All 
Else Fails). Headache Currents 2013; 53(7): 1183-1190. 
8. "Transformed Migraine." National Headache Foundation. 2013. Web. 
http://www.headaches.org/education/Headache_Topic_Sheets/Transformed_Migraine 
 
 
 
Appendix A 
 
Sunday 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
# of daily 
headaches 
within last 
24 hours 
 
 
 
 
 
 
 
Length of 
the 
duration of 
the 
headache 
(mins) 
 
 
 
 
 
 
 
Duration of 
inactivity 
associated 
with the 
headache 
(mins) 
 
 
 
 
 
 
 
Intensity of 
the 
headache 
(0=no 
headache, 
10=worst 
headache 
ever) 
 
 
 
 
 
 
 
Epistaxis 
(blood 
from nose) 
present 
(Y/N) 
 
 
 
 
 
 
 
Nausea/ 
vomiting 
present 
(Y/N) 
 
 
 
 
 
 
 


Statistical Analysis Plan 
 
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines   
 
SAP version I: Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines Date of Version 8/3/2021 
 
Page 15 of 16 
 
 
 
Appendix B: 20 minute follow-up questionnaire 
 
Did the SPG block relieve the headache in the last 20 minutes? 
 
 
 
Appendix C: Asked in post-questionnaire checkup:  
 
Did you modify your usual customary therapy as a result of our therapy? 
 
Rate your satisfaction with the treatment from 1-10 (0=not satisfied, 10=extremely satisfied). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Statistical Analysis Plan 
 
Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines   
 
SAP version I: Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines Date of Version 8/3/2021 
 
Page 16 of 16 
 
Attachment 1 
 
 
 
 
Subject Initials: _____________________ 
Date:      ______________________________________ 
Group: _______________________________________     
  
 
Week 1 
Week 2 
Week 3 
Week 4 
Number of daily headaches 
 
 
 
 
Length of the duration of the headaches (mins) 
 
 
 
 
 
Duration of inactivity associated with the headaches (mins) 
 
 
 
 
Intensity of the headaches (Rate 0-10) 
0= no headache, 10= worst headache ever 
 
 
 
 
 
 
 
 
 
Epistaxis present (Y/N) 
 
Nausea present (Y/N) 
 
 
 
 
 
Vomiting present (Y/N) 
 
 
 
 
 
 
 
 
 
20 minute question if applicable 
Did the SPG block relieve current headache after the 20 
minutes?    
q  Yes 
q  No 
q  N/A 
q  Yes 
q  No 
q  N/A 
q  Yes 
q  No 
q  N/A 
q  Yes 
q  No 
q  N/A 
Asked in post-questionnaire checkup: 
Did you modify your usual customary therapy as a           
result of our therapy? 
q  Yes 
 q  No 
 q  N/A 
q  Yes 
q  No 
q  N/A 
q  Yes 
q  No 
q  N/A 
q  Yes 
q  No 
q  N/A 
 
 
 
 
 
Asked in post-questionnaire checkup: 
Satisfaction with treatment (rate 0-10) 
   0=not satisfied, 10=extremely satisfied 
 
 
 
 
 
 
 
 
 
 

ICF_001.pdf: 
Version 8/3/2021 
 
 
 
CONSENT TO TAKE PART IN A RESEARCH STUDY 
 
TITLE OF STUDY:  A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide 
SPGB Vs. Elavil for the Treatment of Transform Migraine 
Principal Investigator:  William Grubb, MD, DDS 
 
This consent form is part of an informed consent process for a research study and it will provide 
information that will help you to decide whether you wish to volunteer for this research study. It 
will help you to understand what the study is about and what will happen in the course of the 
study. 
 
If you have questions at any time during the research study, you should feel free to ask them and 
should expect to be given answers that you completely understand. 
 
After all of your questions have been answered, if you still wish to take part in the study, you 
will be asked to sign this informed consent form. 
 
The study doctor, William Grubb, MD, DDS, or another member of the study team will also be 
asked to sign this informed consent. You will be given a copy of the signed consent form to 
keep. 
 
You are not giving up any of your legal rights by volunteering for this research study or by 
signing this consent form. 
 
Sponsor of the Study: Department of Anesthesiology, Rutgers-Robert Wood Johnson Medical 
School. 
 
Why is this study being done? 
 
This study is being done to see which therapy, Sphenopalantine Ganglion Block (SPGB) or 
Elavil, is better at treating migraine pain in adult subjects with transformed migraines (chronic 
migraines). A SPGB is a technique in which a small applicator is inserted into the nose to numb 
the area that is involved with causing the migraine pain. We will use 5% lidocaine (common 
numbing agent) with this technique. The other group in the study will receive a commonly used 
medication, Elavil (prescription medication taken by mouth). 
 
Why have you been asked to take part in this study? 
 
You are being asked to participate in this study because you have been diagnosed with 
transformed migraines (chronic migraines). You are an adult referred from a neurologist or other 
health care provider to the Pain Service at Rutgers-Robert Wood Johnson Medical School. 


Version 8/3/2021 
 
Who may take part in this study?  And who may not? 
You may participate in this study if you have been diagnosed with transformed migraines. Also, 
you are between the ages of 18 and 90, and are currently requiring treatment for the migraines, 
and are not being treated with Elavil. You can participate in this study if your background 
medications including any pain medication such as Mortin, Excedrin, Aspirin, or Fioricet or 
narcotic medications such as Percocet, Fiorinal, or other prescribed by your doctor has been 
stable for the past 3 months. You can participate in this study if you have not been responding to 
traditional medical treatments such as triptans (Imitrex, Amerge, Relpax), anticonvulsants 
(Depakote, Lamictal, Klonopin), and/or beta-blockers such as inderal, or catapres. 
 
You may not participate in this study if you are less than 18 years of age or older than 90 years 
of age. Also, you may not participate in this study if you are currently being treated with 
lidocaine (patch or injection) for pain, if you have untreated heart failure, are pregnant (see 
below), or if you are unwilling to follow study procedures and participate in the follow up.  
If you are a female between the ages of 18-50, you will have to accept a urine pregnancy test 
prior to each intervention  
If you become pregnant during the course of the research, you will be withdrawn from the study 
You will be requested to take steps to avoid pregnancy during the course of the study 
You may also not participate in this study if you have an allergy to either lidocaine or Elavil or if 
you have a medical history of hypersensitivity to local anesthetics, including lidocaine 
 
How long will the study take and how many subjects will participate? 
 
We plan to enroll 26  subjects at Rutgers-Robert Wood Johnson Medical School. Your individual 
participation will consist of 4 weeks of active study visits to the Pain Clinic at Rutgers-Robert 
Wood Johnson Medical School. Then the individual will participate in a safety visit 2-4 weeks 
after the active treatment period at week 6.  
 
What will you be asked to do if you take part in this research study? 
 
You will be randomized to one of 2 treatment groups (assigned by a flip of a coin to one of 2 
treatment groups). You will be asked to complete headache questionnaires throughout the study. 
If you are randomized into the SPGB group, you will have blood pressure, heart rate, and pulse 
oximetry (measures the % of oxygen in your blood) readings during the SPGB procedure, and 
you will be asked to complete an additional questionnaire approximately 20 minutes after the 
procedure is completed. Lidocaine, which is the medication that we will be using for the SPGB, 
is standard treatment for pain. SPG with lidocaine gel will be administered weekly for 4 weeks. 
 
If you are randomized into the Elavil group you will receive a prescription from Dr. Grubb for 10 
mg of Elavil by mouth for the first week followed by 20 mg by mouth for the remaining 3 weeks 
of the study which will total 30 days of treatment. You will obtain a prescription at your 
pharmacy for the Elavil. Elavil is a standard of care medication for the treatment of migraines.  
 
 
 
 


Version 8/3/2021 
 
What are the risks and/or discomforts you might experience if you take part in this study? 
 
You may experience minor local discomfort during the SPGB procedure, bitter taste in the back 
of your throat, difficulty talking while the procedure is taking place, difficulty eating and 
drinking for a few minutes to up to 2 hours after the SPGB. You may also notice bloody drainage 
from the nose after the procedure, most notably on the applicator used to apply the lidocaine. 
There are no known psychological/emotional, social, legal and economic risks of harm from the 
SPGB.   
Some minor risks associated with Elavil are nausea, drowsiness, constipation, and dry mouth. 
Because Elavil has potential adverse effects to unborn babies, pregnant women will not be 
included in this study. 
 
A minor risk is the possible loss of anonymity from participation in this study. However, the 
Principal Investigator and his research team have built in protections to avoid and limit this from 
occurring. 
 
Are there any benefits for you if you choose to take part in this research study? 
 
The benefits of taking part in this study may be: 
Either of the treatments could help your headache pain, but there may be no direct benefit 
 
 
What are your alternatives if you don’t want to take part in this study? 
 
 Your alternative is not to take part in this study, and to ask your doctor to provide either of the 
therapies available in the study  
 
How will you know if new information is learned that may affect whether you are willing to 
stay in this research study? 
 
During the course of the study, you will be updated about any new information that may affect 
whether you are willing to continue taking part in the study. If new information is learned that 
may affect you after the study or after your follow-up is completed, you will be contacted. 
 
Will there be any cost to you to take part in this study? 
 
You will not incur extra costs for participating in this study. 
 
Will you be paid to take part in this study? 
 
You will not be paid for your participation in this research study. 
 
 
 
 
 


Version 8/3/2021 
 
How will information about you be kept private or confidential? 
 
All efforts will be made to keep your personal information in your research record confidential, 
but total confidentiality cannot be guaranteed.  
 
All measurements will be recorded on a case report form. All data will be kept in locked file 
cabinets in Dr. Grubb’s office at the Clinical Academic Building Suite 3100, with limited access 
to study personnel. Your study files will be coded with your initials and a unique study number. 
All information will be kept confidential, the link to PHI (Personal Health Information) will be 
stored separate from the study files, and will be destroyed after the completion of the study. 
 
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this website at any time. 
 
What will happen if you are injured during this study? 
 
Subjects in this study will be exposed to certain risks of personal injury, which include: slight 
discomfort during the SPGB procedure and some blood drainage from nose that may be seen on 
the applicator.  In addition, it is possible that during the course of this study, new adverse effects 
of lidocaine and Elavil that result in personal injury may be discovered. The University will 
make appropriate referrals for medical and/or dental treatment for subjects who sustain personal 
injuries or illnesses as a direct consequence of participation in the research. The subject's health 
insurance carrier or other third-party payer will be billed for the cost of this treatment; provided 
that the University shall not submit to federally funded programs, e.g., Medicare, Medicaid or 
CHAMPUS, for reimbursement first if submission to such programs is prohibited by law.  No 
financial compensation will be provided by the University and no other type of assistance is 
available from the University. 
 
What will happen if you do not wish to take part in the study or if you later decide not to 
stay in the study? 
 
Participation in this study is voluntary. You may choose not to participate or you may change 
your mind at any time and seek treatment for your migraines’ by Dr. Grubb and his team.  You 
will still be treated for your migraine headaches by the doctor you have an appointment with 
regardless if you decide to participate in this clinical study, this is considered standard of care 
treatment.   
If you do not want to enter the study or decide to stop participating, your relationship with the 
study staff will not change, and you may do so without penalty and without loss of benefits to 
which you are otherwise entitled. 
 
 
 
 
 
 


Version 8/3/2021 
 
 
You may also withdraw your consent for the use of data already collected about you, but you 
must do this in writing to: 
 
 
     Dr. William Grubb, MD, DDS  
 
     Rutgers-Robert Wood Johnson Medical School 
 
     Clinical Academic Building Suite 3100,  
 
     New Brunswick, NJ 08901 
 
If you decide to withdraw from the study for any reason, you may be asked to return for at least 
one additional visit for safety reasons. 
 
Who can you call if you have any questions? 
 
If you have any questions about taking part in this study or if you feel you may have suffered a 
research related injury, you can call the study doctor: 
 
 
 
William Grubb, MD, DDS 
 
Dept. of Anesthesiology, Rutgers-Robert Wood Johnson Medical School 
 
732-235-7827 
 
 
If you have any questions about your rights as a research subject, you can call: 
 
 
 
IRB Director 
 
(732)-235-9806 New Brunswick/Piscataway 
             
 
What are your rights if you decide to take part in this research study? 
 
You have the right to ask questions about any part of the study at any time.  You should not sign 
this form unless you have had a chance to ask questions and have been given answers to all of 
your questions. 
 
AUTHORIZATION TO USE YOUR HEALTH INFORMATION FOR RESEARCH 
PURPOSES 
 
Because information about you and your health is personal and private, it generally cannot be 
used in this research study without your written authorization (permission). If you sign this 
consent form, it will provide that authorization. The next few paragraphs tell you about how your 
health information will be used or disclosed in the study. Your information will only be used in 
accordance with this authorization and informed consent form as required or allowed by law. 
Because we are committed to protecting your health information, some of the paragraphs that 
follow repeat what we described to you earlier in this consent form about what information we 
will collect about you, how we will use it, when or if it will be shared with others, and the 
measures we will take to protect your privacy and the confidentiality of your personal 
information. 


Version 8/3/2021 
 
 
Please read this authorization section and the consent form carefully. Ask questions if anything is 
not understandable to you. 
 
What is the purpose of this research study and how will my health information be utilized 
in the study? 
 
The purpose of this study is to determine if SPGB is superior to Elavil in the treatment of 
migraine headaches in subjects diagnosed with transformed migraines (chronic migraines). We 
will be using the headache questionnaires that you complete to analyze the study question. We 
do plan to publish or share our results to others in a peer-reviewed journal or at national and 
international conferences.  These are places where specialists discuss the care and treatment of 
your condition in order to help improve the care you receive.  These are generally professional 
meeting that doctors and medical professionals attend to improve the care in their daily practices. 
All clinical trials may be monitored by the FDA (Food and Drug Administration) without notice. 
 
Do I have to sign this authorization form? 
 
You do not have to sign this authorization form. But if you do not, you will not be able to 
participate in this research study and receive any research-related products. However, signing the 
form is not a condition for receiving any medical care outside the study. 
 
If I sign, can I revoke my authorization or withdraw my information later? 
 
If you decide to participate, you are free to withdraw your authorization regarding the use and 
disclosure of your data (and to discontinue any other participation in the study) at any time.  
 
If you wish to revoke your authorization for the research use or disclosure of your data in this 
study, you may do so in writing by contacting: 
 
 
 
 
 
William Grubb, MD, DDS 
 
 
Rutgers-Robert Wood Johnson Medical School 
 
      
Clinical Academic Building Suite 3100,  
 
     
New Brunswick, NJ 08901 
 
 
732-235-7827 
 
What personal information will be used or disclosed? 
 
Your health information related to this study, may be used (disclosed) in connection with this 
research study, including, but not limited to, age, and sex.  All medical information collected 
from or about you in connection with study such as the questionnaires you complete, your 
medical history and medical records you share with us, including any emergency treatment you 
may seek during your participation or during the follow-up in this study, may be shared with the 
agencies listed below who work to ensure your rights as a study subject.  These agencies also 
ensure that the study doctors and his team follow all regulations to ensure your well-being, 
privacy and your overall health and legal rights.  


Version 8/3/2021 
 
 
Who may use or disclose the information? 
 
The following parties are authorized to use and/or disclose your health information in connection 
with this research study: 
 
 The Rutgers University-Institutional Review Board 
 The Research Team in the Department of Anesthesiology 
 Rutgers-Robert Wood Johnson University Hospital 
 FDA 
 The Office for Human Research Protections in the U.S. Department of Health and 
Human Services 
 
Who may receive/use the information? 
 
The parties listed in the preceding paragraph may disclose your health information to the 
following persons and organizations for their use in connection with this research study: 
 
 The Rutgers University-Institutional Review Board 
 The Research Team in the Department of Anesthesiology 
 Rutgers-Robert Wood Johnson University Hospital 
 FDA 
 The Office for Human Research Protections in the U.S. Department of Health and 
Human Services. 
 
When will my authorization expire? 
 
Your authorization for the use and /or disclosure of your health information will expire: “There 
is not a set date at which your authorization will expire. This is because the information used and 
created during the study may be analyzed for many years, and it is not possible to know when 
this will be complete.”  
  
Will access to my research study record be limited during the study? 
 
To maintain the integrity of this research study, you may not have access to any health 
information developed as part of this study until it is completed. At that point, you would have 
access to such health information if it were used to make medical or billing decisions about you 
and was included in your official medical record. 
 
 
 
 
 
 
 
 


Version 8/3/2021 
 
___________________________________________________________________________ 
 
AGREEMENT TO PARTICIPATE 
 
I have read this entire form, or it has been read to me, and I believe that I understand what has 
been discussed.  All of my questions about this form or this study have been answered. 
 
Subject Name: 
 
  
 
 
 
 
 
 
Subject Signature: 
 
  
 
 Date:  
 
 
 
 
Signature of Investigator/Individual Obtaining Consent: 
 
To the best of my ability, I have explained and discussed the full contents of the study including 
all of the information contained in this consent form.  All questions of the research subject and 
those of his/her parent or legal guardian have been accurately answered. 
 
Investigator/Person Obtaining Consent: 
  
 
 
 
 
 
 
Signature:  
 
  
 Date: