Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

• Sponsor: Jamie Bartley, DO (Other)
• Overall Status: Completed
• CT.gov ID: NCT02369068
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 37.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain	Drug: Onabotulinumtoxin A; Drug: Kenalog	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Mar 26, 2018
• Actual Study Completion Date: Sep 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Onabotulinumtoxin A 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; Intravaginal pelvic floor injection one series; Other Names: Botox
Active Comparator: Kenalog 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; Intravaginal pelvic floor injection one series; Other Names: triamcinolone

Outcome Measures

Primary Outcome Measures

1. Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS). [Baseline and One Month]

   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.

2. 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. [Baseline and One Month]

   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.

3. Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [Baseline and One Month]

   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.

4. Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. [Baseline and One Month]

   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).

Secondary Outcome Measures

1. Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [Baseline and Three Months]

   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.

2. 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. [Baseline and Three Months]

   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.

3. Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [Baseline and Three months]

   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.

4. Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire. [Baseline and Three Months]

   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).

5. Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire. [Baseline and Six Months]

   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.

6. 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. [Baseline and Six Months]

   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.

7. Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire. [Baseline and Six months]

   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.

8. Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire. [Baseline and Six Months]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Hospitals	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• Jamie Bartley, DO

Investigators

• Principal Investigator: Jamie Bartley, DO, Beaumont

Study Documents (Full-Text)

• Study Protocol - Sep 12, 2017
• Informed Consent Form - Dec 5, 2017
• Statistical Analysis Plan - Dec 4, 2018

More Information

Publications

None provided.

• Responsible Party: Jamie Bartley, DO, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT02369068
• Other Study ID Numbers: 2015-008
• First Posted: Feb 23, 2015
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Pelvic Pain; Triamcinolone; Triamcinolone Acetonide; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Period Title: 1 Month
STARTED	10	11
COMPLETED	9	10
NOT COMPLETED	1	1
Period Title: 1 Month
STARTED	9	10
COMPLETED	9	8
NOT COMPLETED	0	2
Period Title: 1 Month
STARTED	9	8
COMPLETED	9	7
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Onabotulinumtoxin A	Kenalog	Total
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series	Total of all reporting groups
Overall Participants	10	11	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.4 (11.3)	46.0 (12.8)	46.2 (11.8)
Sex: Female, Male (Count of Participants)
Female	10 100%	11 100%	21 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	11 100%	21 100%
Pain Severity (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.0 (1.7)	4.9 (1.2)	4.9 (1.4)
Pain Interference (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.9 (2.3)	4.7 (2.0)	5.3 (2.2)
Pain Visual Analog Scale (VAS) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	6	5	6

Outcome Measures

1. Primary Outcome

Title	Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
Description	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.
Time Frame	Baseline and One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	10
Median (Full Range) [units on a scale]	-2	-1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Onabotulinumtoxin A, Kenalog
	Comments	The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	Method	Kruskal-Wallis
	Comments	This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.

2. Primary Outcome

Title	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.
Description	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.
Time Frame	Baseline and One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	10
Median (Full Range) [units on a scale]	-0.03	-0.88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Onabotulinumtoxin A
	Comments	The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.624
	Comments
	Method	Kruskal-Wallis
	Comments

3. Primary Outcome

Title	Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
Description	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.
Time Frame	Baseline and One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	10
Median (Full Range) [units on a scale]	-0.14	-0.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Onabotulinumtoxin A
	Comments	The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.571
	Comments
	Method	Kruskal-Wallis
	Comments

4. Primary Outcome

Title	Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Description	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).
Time Frame	Baseline and One Month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	10
Markedly worse	0 0%	0 0%
Moderately worse	1 10%	0 0%
Mildly worse	0 0%	0 0%
Same	2 20%	5 45.5%
Slightly improved	2 20%	4 36.4%
Moderately improved	3 30%	1 9.1%
Markedly improved	1 10%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Onabotulinumtoxin A, Kenalog
	Comments	The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.285
	Comments
	Method	Kruskal-Wallis
	Comments

5. Secondary Outcome

Title	Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
Description	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.
Time Frame	Baseline and Three Months

Outcome Measure Data

Analysis Population Description

At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have the pain assessed using the visual analog scale (missing data for this outcome, analysis conducted on 8 patients).

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	8	8
Median (Full Range) [units on a scale]	-1	-1

6. Secondary Outcome

Title	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.
Description	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.
Time Frame	Baseline and Three Months

Outcome Measure Data

Analysis Population Description

At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain severity (missing data for this outcome, analysis conducted on 8 patients).

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	8	8
Median (Full Range) [units on a scale]	0.25	-0.37

7. Secondary Outcome

Title	Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
Description	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.
Time Frame	Baseline and Three months

Outcome Measure Data

Analysis Population Description

At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain interference (missing data for this outcome, analysis conducted on 8 patients).

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	8	8
Median (Full Range) [units on a scale]	-0.21	-1.0

8. Secondary Outcome

Title	Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Description	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).
Time Frame	Baseline and Three Months

Outcome Measure Data

Analysis Population Description

At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain symptoms using question 2 in the global response assessment (missing data for this outcome, analysis conducted on 8 patients).

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	8	8
Markedly worse	0 0%	0 0%
Moderately worse	0 0%	0 0%
Mildly worse	1 10%	1 9.1%
Same	1 10%	2 18.2%
Slightly improved	1 10%	3 27.3%
Moderately improved	4 40%	1 9.1%
Markedly improved	1 10%	1 9.1%

9. Secondary Outcome

Title	Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
Description	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.
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	7
Median (Full Range) [units on a scale]	-1	-1

10. Secondary Outcome

Title	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.
Description	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.
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	7
Median (Full Range) [units on a scale]	0.0	-1.25

11. Secondary Outcome

Title	Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
Description	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.
Time Frame	Baseline and Six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	7
Median (Full Range) [units on a scale]	-0.71	-1.14

12. Secondary Outcome

Title	Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Description	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).
Time Frame	Baseline and Six Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onabotulinumtoxin A	Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series	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). Kenalog: Intravaginal pelvic floor injection one series
Measure Participants	9	7
Markedly worse	0 0%	0 0%
Moderately worse	1 10%	0 0%
Mildly worse	0 0%	0 0%
Same	2 20%	2 18.2%
Slightly improved	2 20%	2 18.2%
Moderately improved	2 20%	3 27.3%
Markedly improved	2 20%	0 0%

Adverse Events

Time Frame	Adverse event data were collected for a 6 month period of time. Collection started at the initial trigger point injection visit and continued through the 6 month post-injection visit.
Adverse Event Reporting Description	The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definition. Adverse event collection was primarily collected by patient self-report. Additionally, the electronic medical record was reviewed at each visit, labs were evaluated and the physician researcher assessed the patient for adverse events as well.
Arm/Group Title	Onabotulinumtoxin A		Kenalog
Arm/Group Description	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). Onabotulinumtoxin A: Intravaginal pelvic floor injection one series		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). Kenalog: Intravaginal pelvic floor injection one series
All Cause Mortality
	Onabotulinumtoxin A		Kenalog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Serious Adverse Events
	Onabotulinumtoxin A		Kenalog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Onabotulinumtoxin A		Kenalog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/10 (50%)		4/11 (36.4%)
Gastrointestinal disorders
Rectal Spasm	0/10 (0%)	0	1/11 (9.1%)	1
Fecal Incontinence	1/10 (10%)	1	0/11 (0%)	0
Infections and infestations
Bronchitis	0/10 (0%)	0	2/11 (18.2%)	2
Thrush	0/10 (0%)	0	1/11 (9.1%)	1
Pericoronitis	1/10 (10%)	1	0/11 (0%)	0
Musculoskeletal and connective tissue disorders
Lower Extremity Numbness/Weakness	1/10 (10%)	1	0/11 (0%)	0
Rib Fracture	0/10 (0%)	0	1/11 (9.1%)	1
Nervous system disorders
Syncope	1/10 (10%)	1	0/11 (0%)	0
Exacerbation of Radiculopathy	1/10 (10%)	1	0/11 (0%)	0
Renal and urinary disorders
Dysuria	0/10 (0%)	0	1/11 (9.1%)	1
Urinary Tract Infection	2/10 (20%)	3	0/11 (0%)	0
Vaginal Yeast Infection	2/10 (20%)	3	1/11 (9.1%)	1
Increased Pelvic Pain	1/10 (10%)	1	0/11 (0%)	0
Urinary Retention	1/10 (10%)	1	0/11 (0%)	0
Acute Kidney Insufficiency	1/10 (10%)	1	0/11 (0%)	0
Skin and subcutaneous tissue disorders
Facial Abrasions	1/10 (10%)	1	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.