Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain

Conditions
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Pelvic Pain

Intervention / Treatment
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* Drug: Onabotulinumtoxin A
* Drug: Kenalog


Participation Criteria
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Eligibility Criteria
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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 Visual Analog Scale (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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onabotulinumtoxin A<br>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). | Drug: Onabotulinumtoxin A<br>* Intravaginal pelvic floor injection one series<br>* Other names: Botox;|
| Active Comparator: Kenalog<br>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). | Drug: Kenalog<br>* Intravaginal pelvic floor injection one series<br>* Other names: triamcinolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS). | The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased. | Baseline and One Month | 
| Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. | Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 1 month and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased. | Baseline and One Month | 
| Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. | The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores from questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 1 month and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased. | Baseline and One Month | 
| Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. | The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved). | Baseline and One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. | The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 3 months and the visual analog scale at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased. | Baseline and Three Months | 
| Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. | Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 3 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased. | Baseline and Three Months | 
| Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. | The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores together for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 3 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased. | Baseline and Three months | 
| Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. | The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved). | Baseline and Three Months | 
| Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. | The pain visual analog scale (VAS) is a tool used by the patient to describe their pain intensity. Utilizing the VAS, the patient describes their pain at baseline, before receiving trigger point injections. The VAS ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome. | Baseline and Six Months | 
| Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire. | Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 6 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased. | Baseline and Six Months | 
| Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. | The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding together scores for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 6 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased. | Baseline and Six months | 
| Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire. | The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved). | Baseline and Six Months |