Conditions: Pelvic Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief summary:
The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).

Detailed description:
Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.

Arms:
arm 1: Intervention is a one time 30 cc intravaginal injection totaling a dose of 200u of onabotulinumtoxin A and saline injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.

An injection of 30 cc of ropivicaine (5cc/6 sites) will be used, followed by a mixture of 200 u of Onabotulinumtoxin A and 6 cc of saline (1cc/injection site). arm 2: Intervention is a one time 30 cc intravaginal injection totaling a dose of 40mg/cc of Kenalog (triamcinolone) and ropivicaine 0.5% (29cc) injected throughout the pelvic floor at 1, 3, 5, 7, 9 and 11 o'clock sites/locations.

A mixture of 40mg/1 cc of triamcinolone (40 mg) and 29cc of ropivicaine 0.5% (5cc/6 sites) will be used, followed by 6 cc of saline (1cc/injection site).

Interventions: intervention 1: Onabotulinumtoxin A intervention 2: Kenalog
Intervention descriptions: intervention 1: Intravaginal pelvic floor injection one series intervention 2: Intravaginal pelvic floor injection one series

Protocol document:
SAP_002.pdf: 
A DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE ONOBOTULIUMTOXIN A 
VERSUS KENALOG FOR INTRAVAGINAL TRIGGER POINT INJECTIONS IN THE 
TREATMENT OF CHRONIC PELVIC PAIN 
 
 
NCT: 02369068 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
December 4, 2018 
 
 


A DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE ONOBOTULIUMTOXIN A 
VERSUS KENALOG FOR INTRAVAGINAL TRIGGER POINT INJECTIONS IN THE 
TREATMENT OF CHRONIC PELVIC PAIN 
 
Principal Investigator: Jamie Bartley, DO 
 
Statistical Analysis Plan 
 
This study is an exploratory pilot study. Descriptive statistics, provided for all variables, 
are the main focus of the analysis because of the small sample size. Descriptive statistics 
are reported with count (percentages) for categorical variables, and with mean (standard 
deviation) or median (range) for continuous variables, as appropriate. 
 
Exploratory data analysis is focused on comparisons between the two treatment groups. 
Group differences for baseline variables and clinical characteristics at the time of 
treatment were performed. For each subject, the difference in their scores from baseline 
to one month, three months and six months were calculated, respectively.  
 
Kruskal-Wallis tests were used to compare the medians between the groups for the Visual 
Analog Score (VAS) pain score, pain interference and pain severity. Fisher Exact tests 
were used for comparisons of distribution by group of pain assessment with the GRA 
questionnaire. The significance level was set at 0.05 without adjustment for the testing of 
the primary outcomes. No tests were performed at 3 and 6 months since 23.8% of the 
sample was missing due to drop out. 

ICF_001.pdf: 
HIC #2015-008                                                                                                                                         Page 1 of 11  
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CONSENT FORM AND AUTHORIZATION FOR DISCLOSURE OF 
PROTECTED HEALTH INFORMATION 
  
STUDY TITLE:  A DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE 
ONABOTULINUMTOXIN A VS. TRIAMCINOLONE FOR INTRAVAGINAL TRIGGER 
POINT INJECTIONS IN THE TREATMENT OF CHRONIC PELVIC PAIN  
 
Principal Investigator:  Jamie Bartley, DO 
Address: 3601 West 13 Mile Road, Royal Oak, MI 48073 
 
Hospital: William Beaumont Hospital, Royal Oak 
 
 
INTRODUCTION  
Why is this study being done? 
You are being asked to participate in a clinical research study.  The purpose of clinical research 
is to look at the nature of disease and try to develop improved methods to diagnose and treat 
disease. The doctor or clinician in charge of the study believes you meet the initial 
requirements to take part in the study.  Before agreeing to participate, it is important for you 
to read and understand the following explanation of the research procedures.  This Consent 
and Authorization form describes the purpose, procedures, benefits, risks and discomforts of 
the study.  It also describes the alternatives available to you, and your right to withdraw (quit) 
from the study at any time.   
 
Dr. Kenneth Peters, one of the doctors conducting this study at William Beaumont Hospital, 
has received payments from Allergan, the company that makes the study drug, for consulting. 
 
Please read this information carefully and ask as many questions as you like before deciding 
whether or not you would like to take part in this research study. 
 
The goal of this study is to compare the effectiveness of two different medications used in 
intralevator (pelvic) trigger point injections (injections into extremely painful areas of a 
muscle) to treat chronic pelvic pain. We are comparing onabotulinumtoxinA (BOTOX®) (a 
drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to 
triamcinolone (Kenalog) (a synthetic corticosteroid used as an anti-inflammatory agent). 
  
A total of 40 patients will take part in the study here at William Beaumont Hospital, Royal Oak. 
 
How long will I be in the study? 
If you decide to take part in this study, your participation is expected to last approximately six 
months. You may not take part in this study if you are currently enrolled in another related 
research study which could alter or influence the study results. 
 
 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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DESCRIPTION OF THE STUDY 
What will happen if I take part in the research study? 
You are being asked to take part in this research study because you have been diagnosed with 
chronic pelvic pain with trigger points. Chronic pelvic pain has been described as long lasting, 
non-cyclical pain that occurs below the umbilicus. Trigger points are knot-like bands of muscle 
that cause pain when touched. 
 
If you agree to take part in this study you will be randomly assigned to one of two treatment 
groups. Randomization is like “the flip of a coin.” Double-blinded means that neither you nor 
your study doctor will know which medication you receive. In case of an emergency, the 
treatment can be unblinded to determine which therapy you have received. You will be 
randomized to receive either onabotulinumtoxinA with ropivacaine (a “numbing” medication) 
or triamcinolone with ropivacaine for your trigger point injection. 
 
The following will occur at the specified study visits: 
 
Screening Evaluation and Treatment 
The study will be explained to you in detail, and you will have as much time as you need to 
ask questions.  You will be asked to read and sign this Consent and Authorization form before 
any study-related procedures are performed.  The following tests and procedures should be 
done to determine if you qualify to participate in this study: 
 
 Review of your medical history, including an assessment of your last menstrual period 
and contraceptive use. Review of medications you are currently taking and medications 
that you have taken in the past 
 A pregnancy test if you are of child-bearing potential 
 A vaginal examination will be performed by the study clinician to confirm the presence 
of high tone pelvic floor dysfunction (too much tension) and to determine that you do 
not have vaginitis (an inflammation or infection in the vagina). Vaginal pH and wet 
mount (sample of vaginal discharge) will be performed. If you have vaginitis you will be 
given a prescription for the appropriate medication. You may be re-screened 3 days 
after treatment. Also, a ”Q-tip test” is performed. A Q-tip (cotton swab) is used to 
lightly test the vaginal area for pain and tenderness.  Completion of questionnaires 
about your pain 
 Vital signs (blood pressure, pulse, respirations)  
 
You will be eligible for full enrollment into the study after consenting to study participation, 
completing all screening evaluations, and meeting all entry criteria. The intralevator trigger 
point injections may occur at this visit or you may return to the clinic within 7 to 14 days to 
have the treatment.  
 
There will be six injections in the vaginal/pelvic floor area: 1, 3, 5, 7, 9, and 11 o’clock. A 
tampon will then be inserted for approximately 5 minutes. You will be monitored for any side 
effects for a minimum of 30 minutes after the treatment. You will be given an ice pack to 
place on the treatment area, warm blankets and water or juice if you would like. Your vital 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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signs will be taken and you will be asked to give a pain score prior to your discharge from the 
clinic. 
 
One month follow-up visit 
You will return to the clinic approximately 30 days after the treatment and the following 
activities will take place: 
 
 Review of your medical history, including an assessment of your last menstrual period 
and contraceptive use. Review of medications you are currently taking and medications 
that you have taken in the past 
 Evaluation of any new medical events that have occurred since your last visit 
 A vaginal examination to determine that you do not have vaginitis (an inflammation or 
infection in the vagina). Vaginal pH and wet mount (sample of vaginal discharge) will be 
performed. If you have vaginitis you will be given a prescription for the appropriate 
medication. Also, a ”Q-tip test” is performed. A Q-tip (cotton swab) is used to lightly 
test the vaginal area for pain and tenderness. The study doctor will also assess your 
pain at the trigger point(s). 
 Completion of questionnaires about your pain 
 Vital signs (blood pressure, pulse, respirations)  
 
The study doctor will review your treatment results with you and discuss if any additional 
treatment will begin. Permitted treatments include physical therapy, vaginal valium, and repeat 
trigger point injections. Triamcinolone will be used for the injections, but you will not be given 
onabotulinumtoxinA to prevent overdose of onabotulinumtoxinA. If onabotulinumtoxinA 
injections are advised, you would be withdrawn from the study and un-blinded.  
 
Three month follow-up visit 
You will return to the clinic approximately 90 days after the treatment and the following 
activities will take place: 
 
 Review of your medical history, including an assessment of your last menstrual period 
and contraceptive use. Review of medications you are currently taking and medications 
that you have taken in the past 
 Evaluation of any new medical events that have occurred since your last visit 
 A vaginal examination to determine that you do not have vaginitis (an inflammation or 
infection in the vagina). Vaginal pH and wet mount (sample of vaginal discharge) will be 
performed. If you have vaginitis you will be given a prescription for the appropriate 
medication. Also, a ”Q-tip test” is performed. A Q-tip (cotton swab) is used to lightly 
test the vaginal area for pain and tenderness. The study doctor will also assess your 
pain at the trigger point(s). 
 Completion of questionnaires about your pain 
 Vital signs (blood pressure, pulse, respirations)  
 
The study doctor will review your treatment results with you and discuss if any additional 
treatment will begin. Permitted treatments include physical therapy, vaginal valium, and repeat 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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intralevator trigger point injections. Triamcinolone will be used for the injections, but you will 
not be given onabotulinumtoxinA to prevent overdose of onabotulinumtoxinA. If 
onabotulinumtoxinA injections are advised, you would be withdrawn from the study and un-
blinded.  
 
Six month follow-up visit 
You will return to the clinic approximately 180 days after the treatment and the following 
activities will take place: 
 
 Review of your medical history, including an assessment of your last menstrual period 
and contraceptive use. Review of medications you are currently taking and medications 
that you have taken in the past 
 Evaluation of any new medical events that have occurred since your last visit 
 A vaginal examination to determine that you do not have vaginitis (an inflammation or 
infection in the vagina). Vaginal pH and wet mount (sample of vaginal discharge) will be 
performed. If you have vaginitis you will be given a prescription for the appropriate 
medication. Also, a ”Q-tip test” is performed. A Q-tip (cotton swab) is used to lightly 
test the vaginal area for pain and tenderness. The study doctor will also assess your 
pain at the trigger point(s). 
 Completion of questionnaires about your pain 
 Vital signs (blood pressure, pulse, respirations)  
 
The study doctor will review your treatment results with you and discuss if any additional 
treatment will begin. Permitted treatments include physical therapy, vaginal valium, and repeat 
trigger point injections. Triamcinolone will be used for the injections, but you will not be given 
onabotulinumtoxinA to prevent overdose of onabotulinumtoxinA. If onabotulinumtoxinA 
injections are advised, you would be withdrawn from the study and un-blinded.  
 
* While in-person study visits are preferable, the follow up visits may be completed as a phone 
call visit, if the participant is otherwise unable or unavailable. The questionnaires will be 
collected via mail. 
 
In the event the study visit cannot be completed in-person, 
 
 You will receive a telephone call from the study staff to review medications you are 
currently taking and review any problems you may be experiencing. 
 You will be sent the follow up questionnaires to complete and a self-addressed stamped 
envelope for questionnaire return 
 
 
 
FDA Clinical Trial Information  
A description of this clinical trial will be available on http://www.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 Web site at any time.  
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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PARTICIPANT RESPONSIBILITIES  
You should maintain your normal daily activities or physical therapy programs during your 
participation in the research study. You should not start any new medications, therapies or 
exercise programs during the study. Tell a member of the study staff promptly if you start 
taking a new drug or change the dose of an existing drug (including any over-the-counter 
medications or herbal supplements). 
 
You will be asked to note any side effects or medical problems you may experience while you 
are taking part in this study.  For any illnesses or injuries, you should contact the study doctor 
immediately at the number listed on this Consent and Authorization form or in an emergency 
situation call 911 (or go to the nearest hospital emergency room). 
 
 
RISKS, SIDE EFFECTS AND DISCOMFORTS 
Ask your physician what the standard of care risks are as well as the study risks. 
What side effects or risks can I expect from being in the study? 
 
Risks of Trigger Point Injections: 
 
Most Frequent (occurring more than 10% of the time): 
 Slight discomfort during the vaginal exam 
 Light bleeding at the trigger point injection site 
 Pain during the trigger point injection 
 
Rare (occurring less than 1% of the time): 
 Vaginal hematoma (collection of blood in the tissue) 
 Infection 
 
 
Risks of onabotulinumtoxinA: 
Less Frequent (occurring from 1% to 10% of the time): 
 Transient urinary retention (temporary inability to urinate) 
 Transient flatal incontinence (temporary accidental passing of gas) 
 Transient fecal incontinence (temporary accidental loss of stool)  
 Slight temporary fatigue  
 
Rare (occurring less than 1% of the time): 
 Trouble talking 
 Lower extremity weakness  
 Lower extremity numbness 
 
Risks of triamcinolone: 
Rare (occurring less than 1% of the time): 
 Headache  
 Dizziness  
 Weight gain  
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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 Hyperglycemia (high blood sugar) 
 Trouble sleeping  
 
Risks of ropivacaine: 
 
Rare (occurring less than 1% of the time): 
 
 Hypertension (high blood pressure) 
 Hypotension (low blood pressure) 
 Arrhythmia (abnormal heart rate) 
 Tachycardia (rapid heart rate) 
 Headache  
 Rash  
 Lower extremity weakness  
 Urinary retention (inability to urinate) 
 Urinary incontinence (accidental loss of urine) 
 Local anesthetic toxicity (numbing medication could be absorbed through the 
bloodstream into the rest of the body affecting your breathing, heartbeat, blood 
pressure) 
 
 
There is a risk of an allergic reaction from any medication. Symptoms may include swelling, 
skin rash and/or headache. Just to be safe, you should go to the nearest emergency room if 
you were to experience worsening or unexpected difficulty swallowing or talking, trouble 
breathing or muscle weakness.  It is important to know that these symptoms can occur days 
to weeks after an injection of onabotulinumtoxinA.  There may be unknown side effects or 
problems that could result in serious illness or even death.  
 
There is a rare risk of breach of confidentiality (release of information which personally 
identifies you).   
 
Not all possible effects are known. With any medication or therapy, unusual, unexpected or 
previously unreported side effects may occur. You will be informed of any significant new 
findings, which develop during the course of this research study which may change your 
decision to continue participating in this study. 
 
Pregnancy Warning  
If you are a woman who is pregnant or becomes pregnant during the research study, there 
could be harmful effects to you or your unborn child. It is important you not be pregnant or 
breast-feeding during any time in this study. Women of childbearing potential must agree to 
use birth control. If you are a woman of childbearing potential you must have a negative 
pregnancy test before entering the study. 
 
BENEFITS 
What are the benefits of taking part in this study? 
There may be no direct benefit to you from taking part in this study. Your chronic pelvic pain 
may improve, but this cannot be guaranteed. Information gained from the results of this study 
may be of benefit to others in the future, with a similar medical condition.  
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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ALTERNATIVE OPTIONS 
What are my choices other than taking part in this study?   
You do not have to take part in this study to receive treatment for your condition. If you do 
not choose to participate in the study, you can still get trigger point injections and participate 
in other treatments. Other treatments to decrease pain include the use of vaginal valium and 
pelvic floor physical therapy. The risks include: 
 
Risks of Vaginal Valium: 
Rare (occurring less than 1% of the time): 
 Slight Temporary Fatigue 
 Hypotension 
 Weakness 
 Rash 
 
Risks of Pelvic Floor Physical Therapy 
Rare (occurring less than 1% of the time): 
 Temporary muscular pain 
 
ECONOMIC CONSIDERATIONS 
What are the costs of taking part in this study? 
The study medications including onabotulinumtoxinA and triamcinolone (and ropivicaine) will 
be provided to you at no cost for your initial treatment visit. There will be no cost to you for 
the study procedures described in this Consent and Authorization form (for example, 
pregnancy test (1), and questionnaires (5)).  Routine procedures you would have had done 
even if you were not taking part in this study will be billed to your health insurance company 
and/or group health plans as usual (for example, Q-tip test (4-5), vaginal exam (4-5), trigger 
point injection procedure (1-4), triamcinolone and ropivicaine used for additional trigger point 
injections at follow up visits (0-3)). If these routine care costs are not covered by your health 
insurance/group health plan, the cost will be your responsibility.  
 
You will be reimbursed for your time and travel (etc.) during the course of the study. You will 
be paid a total of $75 if you complete all of the study visits. A check for $15.00 will be sent to 
you by William Beaumont Hospital approximately two weeks after the completion of each of 
the five study visits. 
 
COMPENSATION 
What happens if I am injured because I took part in this study? 
Your involvement in this study is voluntary. The possible risks and side effects which might 
occur during the course of the research study have been described in this Consent and 
Authorization form. 
 
A research injury is any physical injury or illness caused by the medications, devices, or 
procedures required by the study which are administered, used, or performed appropriately.  
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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These medications, devices, or procedures are different from the medical treatment you would 
have received if you had not taken part in the study. 
 
Should you experience a research injury, there are no designated funds provided for 
subsequent medical care or compensation by either the study doctor/clinician or William 
Beaumont Hospital.  
 
What are my rights if I take part in this study? 
You are not giving up any of your legal rights by signing this form. 
 
CONFIDENTIALITY, DISCLOSURE AND USE OF YOUR INFORMATION 
Will my medical information be kept private? 
In order for this research study to take place, you must also authorize the researchers to 
access and use some of your protected health information (PHI). PHI is information which 
could identify you as an individual such as name, address, date of birth, etc. By signing this 
Consent and Authorization Form, you give William Beaumont Hospital permission to use and/or 
disclose (release) your health information related to this research. Your medical and billing 
records collected for the purpose of the study will remain confidential, but may be disclosed 
(released) or used by the following and/or their representatives:  
 The investigators (study doctor/clinician, research staff) 
 William Beaumont Hospital  
 The Food and Drug Administration 
 Other governmental regulatory agencies (domestic and/or foreign)  
 Your health insurance company and/or group health plans and their intermediaries 
(companies contracted to process claims) may also have access to your medical and billing 
records of the study. 
 Primary Care Physician  
 
Optional Notification to the Primary Physician 
The research doctor would like to inform your primary physician of your participation in the 
research study.  If you agree, we will need you to give us the name of the primary physician 
to allow us to contact them. 
 
 Yes, I want the study doctor to inform my Primary Care Physician/Specialist of my     
      participation in this study 
  No, I do not want the study doctor to inform my Primary Care Physician/Specialist of my  
      participation in this study 
  I do not have a Primary Care Physician/Specialist 
  The study doctor is my Primary Physician/Specialist 
 
 
________________  
_______________ 
Participant’s Initials  
Date 
 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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The purpose for this disclosure (release) or use is, for example, to assure compliance with the 
study protocol, to evaluate the effectiveness of the study, and/or to provide protection to you 
as a research study participant. The disclosure and use of your information will continue after 
your involvement in the study has ended. There is no expiration date for the use of your 
medical and billing records from the study. Any information about you disclosed to the parties 
identified above may be re-disclosed by them; however, such re-disclosure is not under the 
protections of this Consent and Authorization.  
 
You will not be identified in any publication or other release of study results, data, and other 
information (such as in professional writings, at professional meetings, and in the study 
sponsor’s product information, and/or advertising or other promotional materials).  
 
If you decide to withdraw your authorization for the researchers to access and use your 
personal health information before the end of the study, you will be withdrawn from the 
research study. However, where the study relied on your Consent and Authorization for the 
time you participated in the study, your Consent and Authorization cannot be withdrawn and 
the information already collected may still be used and disclosed as you previously authorized.  
 
STOPPING STUDY PARTICIPATION 
What if I decide to stop taking part in the study? 
Taking part in this research study is completely voluntary. You may choose not to take part or 
to stop being in the study (withdraw) at any time without penalty or loss of benefits to which 
you are otherwise entitled, or without jeopardizing your medical care by your physician at 
William Beaumont Hospital. However, if you do not agree to sign this Consent and 
Authorization form, you will not be able to take part in this study.  
 
If you decide to withdraw from the study you will need to notify the study doctor/clinician, in 
writing, of your decision to stop taking part in the study. This notice may be sent to Dr. Jamie 
Bartley at William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI 48073.  
 
Your participation in this study may be stopped by the study doctor/clinician or study sponsor, 
without your consent, for any reason, which will be explained to you. Examples include: 
 The study medication or procedures appear to be medically harmful to you.  
 You fail to follow directions for participating in the study.  
 It is discovered you do not meet the study requirements.  
 The study is canceled.  
 It is determined to be in your best interest (for example, your disease has progressed 
despite treatment). 
 
If your study doctor/clinician stops your participation, or you decide not to continue, you may 
be asked to have a final study visit or examination, in order for you to be discontinued from 
the study in a safe and orderly manner.  
 
 
 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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CONTACTS 
Who can answer my questions about the study? 
You may talk to the study doctor/clinicians about any questions or concerns regarding your 
study participation, or you think you may have suffered a research-related injury. The 
doctor/clinician in charge of the study, Dr. Jamie Bartley, may be reached at: 248-898-0898 to 
answer your questions.  
 
Your contact person is Amanda Schonhoff, RN. You may contact her at 248-551-1225.  
 
If you have questions regarding your rights as a research participant, or have problems, 
concerns, complaints, want information or would like to offer input, you may contact the 
Institutional Review Board (Human Investigation Committee) Chairperson at (248) 551-0662.  
The Human Investigation Committee is charged with the oversight of all human participant 
research conducted at William Beaumont Hospital facilities. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018


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STATEMENT OF VOLUNTARY PARTICIPATION 
I have read the above, have asked questions and have received answers about this study to 
my satisfaction. I understand what I have read and willingly give my consent to participate in  
A DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE ONABOTULINUMTOXIN A 
VS. TRIAMCINOLONE FOR INTRAVAGINAL TRIGGER POINT INJECTIONS IN THE 
TREATMENT OF CHRONIC PELVIC PAIN. I understand I will receive a signed copy of this 
document and will be promptly informed of any new findings regarding this study.  I further 
authorize the use or disclosure of my health and personal information contained in records as 
described above.  
 
______________________________________ 
RESEARCH PARTICIPANT NAME (PLEASE PRINT) 
 
       
 
______________________________________         ________________   ____________ 
 RESEARCH PARTICIPANT SIGNATURE 
 
 
DATE 
 
 
TIME 
 
ALTERNATIVE SIGNATURE (IF RESEARCH PARTICIPANT UNABLE TO SIGN) 
AS THE PERSONAL/LEGAL REPRESENTATIVE OF THE STUDY PARTICIPANT, PLEASE PRINT PARTICIPANTS NAME ABOVE IN THE RESEARCH 
PARTICIPANT SECTION, AND CHECK ONE OF THE BOXES BELOW AS THE BASIS FOR YOUR AUTHORITY TO SIGN THIS CONSENT AND 
AUTHORIZATION: 
 
 COURT-APPOINTED GUARDIAN 
          
 DURABLE POWER OF ATTORNEY                 
 
 NEXT OF KIN                         
*COURT LETTER IS REQUIRED 
 
         *ATTORNEY LETTER MUST BE PRESENT & VERIFIED BY 2 PHYSICIANS 
 
__________________________________                       ________________________________ 
NAME (PLEASE PRINT) 
 
                                            RELATIONSHIP TO PARTICIPANT    
 
 
_____________________________________                    ________________  
____________ 
SIGNATURE          
 
 
 
 
DATE                           
TIME 
 
 
                   
 WITNESS TO SIGNATURE ON CONSENT       
  WITNESS TO CONSENT PROCESS AND SIGNATURE  
 
______________________________ 
WITNESS NAME (PLEASE PRINT) 
 
_________________________________ 
 
________________ 
____________  
WITNESS SIGNATURE               
 
 
 
DATE 
 
 
TIME 
 
AUTHORIZED CONSENT PROVIDER STATEMENT: 
I have explained this study and have offered the study participant an opportunity for any further 
discussion or clarification. 
 
_________________________________               ____________           ___________________ 
NAME (PLEASE PRINT) 
 
 
                     CREDENTIALS            PHONE NUMBER 
 
_________________________________                 ________________ 
 ____________ 
SIGNATURE 
                                                
DATE   
 
 TIME 
IRB NUMBER: 2015-008
IRB APPROVAL DATE: 12/05/2017
IRB EXPIRATION DATE: 11/29/2018

Prot_000.pdf: 
Page 1 of 14
A DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE ONOBOTULIUMTOXIN A 
VERSUS KENALOG FOR INTRAVAGINAL TRIGGER POINT INJECTIONS IN THE 
TREATMENT OF CHRONIC PELVIC PAIN
Principal Investigator: Jamie Bartley, DO
Version Date: August 23, 2017
Study Overview
Background
Chronic pelvic pain (CPP) is a common and often debilitating problem among women. 
A practical clinical definition of CPP is non-cyclical pelvic pain that is of at least 6 
months duration1.   CPP occurs below the umbilicus and is severe enough to cause 
functional impairment or require treatment.  CPP affects approximately 15% of women 
and the health care burden is substantial.  The direct cost of physician/clinician visits is 
estimated to be over $880 million and the indirect costs due to lost work is estimated at 
$555 million2.  
Patients with CPP often go undiagnosed for years and see many different healthcare 
providers before getting the correct diagnosis and subsequent improvement in their 
symptoms3, 4.  Depending on the treating specialists, patients may be diagnosed with 
bladder pain syndrome/interstitial cystitis (BPS/IC), endometriosis, vulvodynia, or 
irritable bowel syndrome.  A definitive diagnosis may be lacking in up to 60% of 
patients seeking treatment for CPP5.  Patients with CPP report that their quality of life is 
diminished and their relationships with loved ones are often damaged6, 7.  They may 
have lost their job as a result of missed work days or inability to function appropriately 
due to pelvic pain symptoms.  
The musculoskeletal system is an important factor in chronic pelvic pain, specifically 
the persistent and refractory type8.  Myofascial pain and hypertonic pelvic floor 
dysfunction are present in as many as 85% of patients with bladder pain 
syndrome/interstitial cystitis and/or chronic pelvic pain syndromes9. The pelvic floor 
muscles are arranged in deep and superficial layers and act as a sling to support the 
pelvic organs and the bones and ligaments of the pelvis provide support to the pelvic 
muscles. The deep levator ani muscles, often referred to as the pelvic diaphragm, are 
the most important of the pelvic floor muscles and consist of the pubococcygeus, 
iliococcygeus, and the coccygeus.  The main function of the muscles are to control 
continence and both bowel and urine elimination. 
 An important concept to understand when treating pelvic pain is that of cross-system 
interactions.  This is a loss of peripheral specificity when a stimulus arrives in the 
central nervous system making it difficult to sort out the exact source of the stimulus10.  
In the case of pelvic floor dysfunction, the levator muscles may be stretched and 
irritated but the patient may perceive it as bladder pain or vaginal pain.  Studies have 
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Page 2 of 14
demonstrated that women with CPP had more frequent musculoskeletal findings and 
had less control over their pelvic floor compared to control subjects11.  On physical 
examination, myofascial trigger points have been described.  These hyperirritable 
bands of muscle can be palpated through the vaginal walls.  They are often knot- like or 
taut and are painful on compression, reproducing the patient’s pain symptoms12,13.   
Trigger points are thought to be discreet areas of abnormal muscle spasms whereas 
high-tone pelvic floor muscle dysfunction (HT-PFD) refers to a more global pelvic floor 
hypertonicity causing diffuse spasm of the levator complex14. Both have been 
implicated in chronic pelvic pain but in our experience, patients with chronic pelvic pain 
present with more global pelvic floor hypertonia than one area of tenderness as the 
term trigger point would suggest. 
Prior studies of treatments directed towards hypertonic pelvic floor dysfunction in 
women with CPP have been promising. In a recent NIH-funded multicenter study, 
investigators found that 59% of patients receiving myofascial physical therapy reported 
moderate or marked improvement in their symptoms compared to 29% of the control 
group of patients receiving global therapeutic massage15.  This and other studies have 
resulted in pelvic floor physical therapy to be first line treatment of women with chronic 
pelvic pain and hypertonic pelvic floor dysfunction16.
In patients that fail non-invasive techniques, intralevator trigger point injections (TPIs) 
are often the next step.  This is often combined with physical therapy and typically 
requires 3-5 injections to help the muscle relax and return to normal function.   Langford 
and coworkers injected palpable vaginal trigger points with 5cc of a mixture of 10 cc of 
0.25% bupivacaine, 10 cc of 2% lidocaine and 1cc of 40 mg triamcinolone17.  Success, 
defined as a decrease in pain of 50% or more, occurred in 73% (13/18) with 33% (6/18) 
being completely pain free.  
 
Intralevator trigger point injections with onabotulinumtoxinA has also been shown to 
improve pain in patients with chronic pelvic pain and is often the next step following 
steroid trigger point injections.  Typically we use this for patients that respond to steroid 
TPIs but the effects are not long lasting.  OnabotulinumtoxinA has been shown to 
provide relief for 6-9 months with minimal side effects including, infection, hematoma, 
and pain all of which are similar to traditional TPI16.   
In a study of 30 patients that received 80 units of  onabotulinumtoxinA and 30 patients 
that received placebo (saline) injection into the pelvic floor muscles for dysmenorrhea, 
dyspareunia, dyschezia, and nonmenstrual pelvic, there was a significant change in 
baseline in the onabotulinumtoxinA  group in nonmenstrual pelvic pain18.  Both groups 
had changes in dyspareunia and pelvic floor pressures (cm H20) but these patients 
were also allowed to undergo pelvic floor physical therapy during the course of 
treatment, which may have affected the results in both groups.  OnabotulinumtoxinA  
150U-400U has also been shown to be very effective in treatment of women with 
refractory vaginismus19.
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OnabotulinumtoxinA  injection has been compared to 80 mg methylprednisone  injection 
in patients with chronic myofascial pain in the piriformis (100u), iliopsoas (150u) or 
scalenus anterior (80u) muscles and was found to have similar results at 30 days but at 
60 days the  onabotulinumtoxinA group had statistically significant improvements in their 
pain scores, compared to the methylprednisone group and also compared to their 
scores at 30 days20. 
As discussed above, onabotulinumtoxinA is often used for patients that have failed 
conservative therapy with medications, pelvic floor physical therapy and/or steroid 
trigger point injections.  However, the optimal dosing and frequency of use has not been 
determined and needs further study.   In addition, the effect of onabotulinumtoxinA  
injections on the need for additional therapy is unclear but may be beneficial for several 
reasons.  First, if relief is able to be maintained over a longer time period initially, 
patients may be able to avoid having to undergo repeated TPI over 3 to 5 sessions 
which can be painful, costly, and time consuming and they may progress to needing  
onabotulinumtoxinA  anyway.  Second, by providing more immediate and prolonged 
relief, requirements for other therapies such as pelvic floor physical therapy and narcotic 
pain medications may be reduced.  Third, because many of our patients with pelvic pain 
present with high tone pelvic floor dysfunction, we expect global intralevator trigger point 
injections to be more effective than single site injections. Lastly, we know that chronic 
pelvic pain is associated with anxiety and depression and we hope that the more 
immediate and prolonged result of onabotulinumtoxinA will provide patients with 
improved mental health scores.
Objectives and/or Endpoints 
The primary objective of this study is to assess changes in overall pain score using 
the visual analog scale (VAS) (Appendix 1), the Brief Pain Inventory (BPI) 
(Appendix 2) and Global Response Assessment (GRA)(Appendix 3) questionnaire 
at one month following transvaginal trigger point injections with a steroid 
(triamcinolone) and a local anesthetic (ropivacaine) vs. onabotulinumtoxinA and a local 
anesthetic (ropivacaine) in patients with CPP and high-tone pelvic floor dysfunction. We 
hypothesize that patients in the Botox group will have lower pain scores following 
treatment and that the treatment will have a longer effect compared to patients in the 
Kenalog group. 
The secondary objective is to determine if there are persistent changes in pain scores 
using the VAS, BPI, and GRA at 3 and 6 month follow up. Lastly, patients will be asked 
to complete a questionnaire to determine what other treatments have been needed 
since the original TPI (Appendix 4).    
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Patients will be asked to refrain from any additional treatments including pelvic floor 
physical therapy, or new prescriptions for intravaginal muscle relaxants or narcotic 
medications during the first month following the initial TPI.  If patients are already taking 
muscle relaxants or narcotics, they will need to either remain stable or decrease the 
dosage and frequency of the medication.  If patients are already receiving pelvic floor 
physical therapy, they may continue treatment. If patients require increased use of 
these medications or additional therapies due to worsening or uncontrolled symptoms, 
these treatments will be provided at the discretion of the treating clinician.  These 
patients will then be evaluated as an intention to treat cohort. In addition, at the one 
month follow-up visit with the clinician, further treatments will be offered based on the 
patient’s need for further symptom control.   
We hope that the information obtained by this study will help guide clinicians to make an 
evidenced based decision on the clinical efficacy as well as cost effectiveness of two 
transvaginal trigger point injection protocols for patients with high-tone pelvic floor 
dysfunction. 
Methodology
A randomized, double blind two arm study.  Up to 40 women will be included to 
complete this study. We may enroll up to 60 patients to account for possible dropouts, 
with each arm having up to 20 subjects.  This is a pilot trial and a formal sample size 
has not been completed.  Subjects will be recruited by physician referral or word of 
mouth.  Study activities will take place at the Women’s Urology Center in the south 
tower of Beaumont Hospital, Royal Oak.
Screening
Subjects are eligible to participate in this study if they are a woman greater than 18 
years old and have pain localized to the pelvis for greater than 3 months. Overall pelvic 
pain score must be greater than 4 on the VAS. They will be screened with assessment 
of last menstrual period (LMP) and a urine pregnancy test.  If the woman has had a 
tubal ligation or a hysterectomy, the pregnancy test will be waived. 
A vaginal exam will be performed obtaining a pH and wet mount.  If the woman has 
vaginitis on her wet mount at screening, she may be given a prescription for the 
appropriate medication per standard of care and be re-screened. She must wait at least 
3 days after treatment and may be re-screened once. The vaginal exam will also include 
a levator exam and the patient must have the finding of high tone pelvic floor 
dysfunction.  This will be determined by the clinician and is defined as diffuse spasms 
and pain with palpation of the levator complex. Pain scores from 0-10 on the VAS will 
be recorded according to positions on a clock as rated by the patient (Figure 1).  
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Page 5 of 14
Informed consent will be obtained from women meeting the screening and inclusion 
criteria (see below). 
Following screening, consent and enrollment, a complete medical history will be 
obtained and/or confirmed from a prior visit.  The intake form will be the same history 
form that all patient’s presenting to the Women’s Urology Center are asked to fill out.  
Information obtained includes demographics, current and past medical conditions, 
surgical history, social history (smoking, drugs, education, caffeine use, and 
employment), current medications, and allergies.  Past treatment history for pelvic pain 
including physical therapy, trigger point injections, hydrodistension, cystoscopy, and 
surgery will be recorded.   Subjects in both groups will then be asked to fill out baseline 
questionnaires including pain score on the VAS and the BPI.   
The woman will then be randomized to one of 2 treatment arms in a 1:1 pattern.
Proposed intervention, if applicable (e.g., study visits, surgical procedure, 
administration of drugs, etc.) or collection of data (e.g., survey, questionnaire, 
etc.).
Subject enrollment and treatment may both occur at the initial visit.  If desired, these 
visits may also be scheduled as separate visits within a 7-14 day period of time.   
The first arm (Group 1) will receive TPI with a steroid and a local anesthetic followed by 
saline and the second arm (Group 2) will receive a local anesthetic followed by a 
mixture of 200u of Onabotulinumtoxin A and saline.   Each group will receive injections 
globally throughout the pelvic floor at 1, 3, 5, 7, 9, 11 o’clock (Figure 1). See below.
Intralevator trigger point injections will then be performed as follows:  With the subject in 
lithotomy position and blinded by a drape, the clinician will perform a pelvic exam to 
palpate the muscles of the levator complex.  Pain scores from 0-10 on the VAS will be 
recorded according to positions on a clock as rated by the patient.  The pharmacy will 
provide the injection medications in dark syringes in the following solutions:  For 
patients randomized to group 1, a mixture of 40mg/1 ml of triamcinolone (40 mg) and 
29cc of ropivicaine 0.5% (5cc/6 sites) will be used first followed by 6 cc of saline 
(1cc/injection site).  In Group 2, patients will receive an injection of 30 cc of ropivicaine 
(5cc/6 sites) followed by a mixture of 200 u of onabotulinumtoxinA and 6cc of saline.  In 
patients weighing less than 58kg, the ropivicaine dose will be adjusted to a maximum of 
2.5mg/kg/dose.  A 7 inch 22 gauge spinal needle and a needle guide will be used to 
administer the injections.  A tampon will be inserted following the injection for 
approximately 5 minutes and then removed.
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Page 6 of 14
Subjects will be monitored for at least 30 minutes following TPI.  An ice pack to the 
vulva, warm blanket and water or juice will be provided as needed for patient comfort.  
Side effects will be monitored by assessing vital signs (Blood pressure, pulse, 
respirations) within 10 minutes of the injection by the clinical staff (medical assistants) 
and monitoring subject-reported symptoms such as those most commonly noted with 
trigger point injection such as pain, hematoma, light-headedness, and hypertension (all 
<1 %).  Vital signs and any adverse effects will be reported to the study physician 
performing the injections.  An overall pelvic pain score (0-10) prior to departure will be 
obtained
For in office follow up visits the following will take place:
30 days (+/- 7 days) following the first TPI, the subjects will return to the WUC for a 
follow up visit.  Follow up questionnaires will be given (VAS, BPI, GRA) and subjects will 
have an office visit with one of the study clinicians.  A pelvic exam will be performed and 
levator pain scores from 0-10 on the VAS will be recorded according to positions on a 
clock as rated by the patient.  The subject’s symptoms will be assessed and other 
treatments will be initiated as needed.
90 days (+/- 30 days) following the initial TPI, patients will return to the WUC for a follow 
up visit.  Pelvic pain scores will be assessed using the VAS and BPI.  GRA will also be 
determined.  Patients will be asked to fill out a questionnaire regarding other treatments 
they have had since the initial TPI (Appendix 4).  A pelvic exam will be performed by the 
study clinician and levator pain scores from 0-10 on the VAS will be recorded according 
to positions on a clock as rated by the patient.
At 180 days (+/- 30 days) following the initial TPI, patients will return to the WUC for a 
follow up visit and a study exit interview.  The VAS, BPI, GRA and additional treatments 
questionnaires will be obtained.  A pelvic exam will again be performed by the study 
clinician and pain scores from 0-10 on the VAS will be recorded according to positions 
on a clock as rated by the patient.
* While in-person study visits are preferable, the follow up visits may be completed as a 
phone call visit, if the participant is otherwise unable or unavailable. The questionnaires 
will be collected via mail.
In the event the follow up study visit is not conducted in-person, the visit may be 
conducted by phone and/or mail and Research Staff will:

Send the follow up questionnaires to the participant for completion with a self-
addressed Stamped envelope for questionnaire return

Review the questionnaires and completion dates with the participant
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
Request and verify the completed questionnaires have been returned to the 
research office

Contact the participant for clarification and/or to address questions regarding the 
completed questionnaires, if needed

Assess concomitant medication changes

Assess for adverse events
Subjects may be permitted to withdraw from the study if they have poor resolution of 
their pain or worsening of their symptoms.  If they feel that they need other therapy 
during the first 30 days that is not permitted by the study (additional physical therapy, 
higher or more frequent doses of vaginal valium or  pain medications, repeat TPI, etc.) 
they may be withdrawn and will be evaluated by the clinician for other treatment options. 
Patients who withdraw from the study will be asked if they are willing to fill out post 
questionnaires. Either group can get additional therapy following the first 30 days 
following the TPI.  Furthermore, either group may have repeat TPI with kenalog one 
month following the original injection but patients may not undergo TPI with 
onabotulinumtoxinA following the original injection unless they withdraw from the study 
and are unblinded to prevent overdose of onabotulinumtoxinA.  If additional TPIs with 
kenalog and ropivicaine are indicated at any of the follow up visits, the injections will be 
prepared and administered in the Woman’s Urology Center, per routine standard of 
care.  In no way will their withdrawal from the study impact what treatments will be 
offered to them.  Subjects may also withdraw from the study without any reason given.   
If they do not feel comfortable continuing treatment by the study clinicians or at the 
WUC, they will be referred to another provider/site not involved in the study.  
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Schedule of Activities
Initial Visit
Screening
Consent
Treatment Visit
Baseline 
Questionnaires and 
physical exam
(May be done at initial 
visit)
30 days
90 days
180 days
Screening
X
Consent
X
Intake medical history form
X
X (If not done at initial 
visit)
Urine pregnancy testa
X
Q tip test 
X
X
Xb
Xb
Xb
Vaginal pH and wet mount
X
X (As needed)
Xb (As needed)
Xb (As needed)
Xb (As needed)
Assess concomitant meds
X
X
X
X
X
Vaginal exam assessment 
for high tone pelvic floor 
dysfunction with record of 
patient reported levator pain 
scores
X
X
Xb
Xb
Xb
Vital signs
X
X
Xb
Xb
Xb
Total overall pelvic pain 
score on VAS
X
X (done pre and post 
TPI)
X
X
X
BPI
X 
X
X
X
Trigger point injection
X
As needed
As needed
As needed
Assess side effects
X
X
X
X
GRA
X
X
X
Assess concomitant 
treatments
X 
X
X
X
aPremenopausal women that have not had a tubal ligation or hysterectomy
bOnly applies to follow up visits completed in office
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Risks and Benefits
The benefit of this study is that it will guide clinicians to make an evidenced based 
decision on the clinical efficacy as well as cost effectiveness of two different means of 
intravaginal trigger point injections for patients with PFD.  We hope that identification of 
successful therapies will improve patient’s quality of life, decrease the requirement for 
narcotic pain medications and decrease medical costs to the patient.
In this patient population, pain during the exam and trigger point is common and 
expected.  However, the goal of this treatment is to decrease the pain long term.  
Anecdotally, patients are able to put up with temporary pain during the treatment to gain 
the benefit of prolonged relief that comes with injections.  
Potential risks to the subject include:
Risks of Trigger Point Injections:
Most Frequent (occurring more than 10% of the time):

Slight discomfort during the vaginal exam

Light bleeding at the trigger point injection site

Pain during the trigger point injection
Rare (occurring less than 1% of the time):

Vaginal hematoma (collection of blood in the tissue)

Infection
Risks of OnabotulinumtoxinA:
Less Frequent (occurring from 1% to 10% of the time):

Transient urinary retention (temporary inability to urinate)

Transient flatal incontinence (temporary accidental passing of gas)

Transient fecal incontinence (temporary accidental loss of stool) 

Slight temporary fatigue 
Rare (occurring less than 1% of the time):

Botox toxicity/intolerance 

Lower extremity weakness 

Lower extremity numbness
Risks of Kenalog:
Rare (occurring less than 1% of the time):

Headache 

Dizziness 

Weight gain 

Hyperglycemia (high blood sugar)

Trouble Sleeping 
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Risks of Ropivacaine:
Rare (occurring less than 1% of the time):

Hypertension (high blood pressure) 

Hypotension (low blood pressure)

Arrhythmia (abnormal heart rate)

Tachycardia (rapid heart rate)

Headache 

Rash 

Lower extremity weakness 

Urinary retention (inability to urinate)

Urinary incontinence (accidental loss of urine)

Local anesthetic toxicity (numbing medication could be absorbed through the 
bloodstream into the rest of the body affecting your breathing, heartbeat, blood 
pressure)
There is a risk of an allergic reaction from any medication. Symptoms may include 
swelling, skin rash and/or headache, difficulty swallowing or talking, trouble breathing, 
muscle weakness. Symptoms can occur days to weeks after injection. There may be 
unknown side effects or problems that could result in serious illness or even death.
Inclusion Criteria

Provide informed consent

Healthy women > age 18 regardless of menopausal status

Willing and able to fill out study questionnaires.  In patients that are unable to 
read, the research nurse will be available to assist.

High-tone pelvic floor dysfunction on vaginal exam

A pelvic pain score of  > 4  on screening VAS

Pain perceived to be in the pelvis that has been present for at least 3 months.  
 Exclusion Criteria

Patients that have had Botox to the bladder within the last 8 months

Patients that have had Botox outside the bladder of > 160 u within the last 12 
weeks.

Patients that have had transvaginal trigger point injections of any form (Botox or 
steroid) in the last 3 months

Pregnancy

Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the 
study period that could be deemed unsafe in combination with study medication 
as judged by the investigators.

Any evidence of vaginitis on wet mount slide at initial visit that is untreated.

Subject with any other vaginal epithelial disorder that could affect absorption of 
medication as deemed by the investigators.
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
Any indication/condition/medication that the investigators identify as 
contraindicated in conjunction with study medication.

Systolic blood pressure > 160 mm Hg on screening blood pressure

Heart rate > 110 beats/minute on screening heart rate
Randomization
Subjects will be randomized to one of the two trigger point injection types by a sealed 
randomization envelopes (or similar randomization) created by our biostatistician. 
Patients will be randomized in a 1:1 pattern in varied randomized block design.
Recruitment
We anticipate recruitment will come from volunteers with pelvic pain both within and 
outside the Beaumont health care system urology and gynecology practices by 
physician referral and word of mouth. 
Data Analysis
This study is an exploratory pilot study. Descriptive statistics, which will be provided for 
all variables, will be the main focus of the analysis because of the small sample size. 
Descriptive statistics will consist of frequency tables and bar charts for categorical 
variables, as well as summary statistics tables and boxplots for continuous variables. 
Exploratory data analysis will be conducted on the data, particularly focusing on 
comparisons between the two treatment groups. Formal significance testing will be 
done to analyze group differences in terms of the baseline variables and clinical 
characteristics at time of treatment.
Since both the VAS and the BPI scores are given on ordinal scales, the marginal 
distributions of each of these scores will be provided for both time of treatment and 30 
days after. For each subject, the difference in their score from pre to post will be 
calculated. Frequencies will be tabulated for the number of subjects whose pain score 
improved the number whose pain score stayed the same, and the number whose pain 
score worsened. The proportion of subjects in these categories will be compared 
between groups. Bar graphs will be created to illustrate the distribution of this variable. 
Nonparametric tests may be used to compare groups based on the distribution of the 
outcome variables. 
Data Safety Monitoring Plan
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An independent physician (not connected with the study, but familiar with the use of 
trigger point injections) will review study records at the half-way point of enrollment for 
each arm of the study to ensure the safety of subjects and lack of significant adverse 
effects.  As an on-going plan, any adverse effects (prolonged bleeding, hemodynamic 
changes, significant patient pain, or other deemed significant by clinicians) will be 
reported to the research nurse and then to the PI at the time of the event. Adverse 
events, serious adverse events, and unanticipated problems not listed in the risks 
section of this protocol will be reported per federal regulations and IRB guidelines.
Stipend 
Participants will receive a check for $15 from William Beaumont Hospital following each 
of the five study visits. A total stipend of $75 will be paid to those who complete all study 
visits. 
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Ortiz DD: Chronic pelvic pain in women. American family physician 77(11), 1535-
1542 (2008).
2. 
Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF: Chronic 
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3.
Driscoll A, Teichman JM: How do patients with interstitial cystitis present? The 
Journal of urology 166(6), 2118-2120 (2001).
4.
Nickel JC, Kaufman DM, Zhang HF, Wan GJ, Sand PK: Time to initiation of 
pentosan polysulfate sodium treatment after interstitial cystitis diagnosis: effect 
on symptom improvement. Urology 71(1), 57-61 (2008).
5.
Zondervan KT, Yudkin PL, Vessey MP, Dawes MG, Barlow DH, Kennedy SH: 
Patterns of diagnosis and referral in women consulting for chronic pelvic pain in 
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6. 
Suskind AM, Berry SH, Suttorp MJ et al.: Health-related quality of life in patients 
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7.
Nickel JC, Tripp DA, Pontari M et al.: Psychosocial phenotyping in women with 
interstitial cystitis/painful bladder syndrome: a case control study. The Journal of 
urology 183(1), 167-172 (2010).
8.  
Diatchenko L, Nackley AG, Slade GD, Fillingim RB, Maixner W: Idiopathic pain 
disorders--pathways of vulnerability. Pain 123(3), 226-230 (2006).
9.  
Peters KM, Carrico DJ: Frequency, urgency, and pelvic pain: treating the pelvic 
floor versus the epithelium. Current urology reports 7(6), 450-455 (2006).
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Bielefeldt K, Gebhart GF: Textbook of pain. (5th). Elsevier, 721-736 (2006).
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Tu FF, Holt J, Gonzales J, Fitzgerald CM: Physical therapy evaluation of patients 
with chronic pelvic pain: a controlled study. American journal of obstetrics and 
gynecology 198(3), 272 e271-277 (2008).
12. 
Alvarez DJ, Rockwell PG: Trigger points: diagnosis and management. American 
family physician 65(4), 653-660 (2002).
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13.
Janicki TI: Chronic pelvic pain as a form of complex regional pain syndrome. 
Clinical obstetrics and gynecology 46(4), 797-803 (2003).
14.       Goldstein AT, Burrows LJ, Kellogg-Spadt S: Intralevator injection of botulinum 
toxin for the treatment of hypertonic pelvic floor muscle dysfunction and 
vestibulodynia. J Sex Med 8 (5): 1287-90 (2011). 
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IRB NUMBER: 2015-008
IRB APPROVAL DATE: 09/12/2017