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Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369068
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : February 6, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jamie Bartley, DO, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pelvic Pain
Interventions Drug: Onabotulinumtoxin A
Drug: Kenalog
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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: 3 Months
Started 9 10
Completed 9 8
Not Completed 0 2
Period Title: 6 Months
Started 9 8
Completed 9 7
Not Completed 0 1
Arm/Group Title Onabotulinumtoxin A Kenalog Total
Hide 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 Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
46.4  (11.3) 46.0  (12.8) 46.2  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
10
 100.0%
11
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10 11 21
Pain Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 11 participants 21 participants
5.0  (1.7) 4.9  (1.2) 4.9  (1.4)
[1]
Measure Description: Pain severity was constructed by averaging questions 3,4,5 and 6 of the Brief Pain Inventory (BPI) 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.
Pain Interference   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 11 participants 21 participants
5.9  (2.3) 4.7  (2.0) 5.3  (2.2)
[1]
Measure Description: The Pain Interference score was constructed by averaging the individual interference question scores from the BPI questionnaire (scores for questions 9A-9G added together and divided 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.
Pain Visual Analog Scale (VAS)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 10 participants 11 participants 21 participants
6
(5 to 8)
5
(4 to 7)
6
(4 to 8)
[1]
Measure Description: The pain visual analog scale (VAS) is a tool used by the patient to describe the intensity of their pain. Utilizing the visual analog scale, the patient describes their pain at baseline, before receiving trigger point injections. The visual analog scale ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome.
1.Primary Outcome
Title Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 10
Median (Full Range)
Unit of Measure: units on a scale
-2
(-4 to 0)
-1
(-2 to 3)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 10
Median (Full Range)
Unit of Measure: units on a scale
-0.03
(-1.75 to 3.25)
-0.88
(-1.25 to 2.0)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 10
Median (Full Range)
Unit of Measure: units on a scale
-0.14
(-4.71 to 3.57)
-0.36
(-1.86 to 2.29)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Primary Outcome
Title Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
Markedly worse
0
   0.0%
0
   0.0%
Moderately worse
1
  11.1%
0
   0.0%
Mildly worse
0
   0.0%
0
   0.0%
Same
2
  22.2%
5
  50.0%
Slightly improved
2
  22.2%
4
  40.0%
Moderately improved
3
  33.3%
1
  10.0%
Markedly improved
1
  11.1%
0
   0.0%
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8
Median (Full Range)
Unit of Measure: units on a scale
-1
(-4 to 0)
-1
(-2 to 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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8
Median (Full Range)
Unit of Measure: units on a scale
0.25
(-1.75 to 2.75)
-0.37
(-2.75 to 3.25)
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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8
Median (Full Range)
Unit of Measure: units on a scale
-0.21
(-2.71 to 2.0)
-1.0
(-3.71 to 3.71)
8.Secondary Outcome
Title Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
Markedly worse
0
   0.0%
0
   0.0%
Moderately worse
0
   0.0%
0
   0.0%
Mildly worse
1
  12.5%
1
  12.5%
Same
1
  12.5%
2
  25.0%
Slightly improved
1
  12.5%
3
  37.5%
Moderately improved
4
  50.0%
1
  12.5%
Markedly improved
1
  12.5%
1
  12.5%
9.Secondary Outcome
Title Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 7
Median (Full Range)
Unit of Measure: units on a scale
-1
(-6 to 2)
-1
(-5 to 2)
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 7
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-1.75 to 4.0)
-1.25
(-1.75 to 2.75)
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.
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 7
Median (Full Range)
Unit of Measure: units on a scale
-0.71
(-1.71 to 4.0)
-1.14
(-5.0 to 2.43)
12.Secondary Outcome
Title Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onabotulinumtoxin A Kenalog
Hide 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

Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
Markedly worse
0
   0.0%
0
   0.0%
Moderately worse
1
  11.1%
0
   0.0%
Mildly worse
0
   0.0%
0
   0.0%
Same
2
  22.2%
2
  28.6%
Slightly improved
2
  22.2%
2
  28.6%
Moderately improved
2
  22.2%
3
  42.9%
Markedly improved
2
  22.2%
0
   0.0%
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
Hide 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 (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Onabotulinumtoxin A Kenalog
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Onabotulinumtoxin A Kenalog
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      4/11 (36.36%)    
Gastrointestinal disorders     
Rectal Spasm *  0/10 (0.00%)  0 1/11 (9.09%)  1
Fecal Incontinence *  1/10 (10.00%)  1 0/11 (0.00%)  0
Infections and infestations     
Bronchitis *  0/10 (0.00%)  0 2/11 (18.18%)  2
Thrush *  0/10 (0.00%)  0 1/11 (9.09%)  1
Pericoronitis *  1/10 (10.00%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lower Extremity Numbness/Weakness *  1/10 (10.00%)  1 0/11 (0.00%)  0
Rib Fracture *  0/10 (0.00%)  0 1/11 (9.09%)  1
Nervous system disorders     
Syncope *  1/10 (10.00%)  1 0/11 (0.00%)  0
Exacerbation of Radiculopathy *  1/10 (10.00%)  1 0/11 (0.00%)  0
Renal and urinary disorders     
Dysuria *  0/10 (0.00%)  0 1/11 (9.09%)  1
Urinary Tract Infection *  2/10 (20.00%)  3 0/11 (0.00%)  0
Vaginal Yeast Infection *  2/10 (20.00%)  3 1/11 (9.09%)  1
Increased Pelvic Pain *  1/10 (10.00%)  1 0/11 (0.00%)  0
Urinary Retention *  1/10 (10.00%)  1 0/11 (0.00%)  0
Acute Kidney Insufficiency *  1/10 (10.00%)  1 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders     
Facial Abrasions *  1/10 (10.00%)  1 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deborah Hasenau RN, Director, Urology Research
Organization: Beaumont Hospital, Royal Oak
Phone: 248-551-0804
EMail: Deborah.Hasenau@Beaumont.org
Layout table for additonal information
Responsible Party: Jamie Bartley, DO, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT02369068     History of Changes
Other Study ID Numbers: 2015-008
First Submitted: February 5, 2015
First Posted: February 23, 2015
Results First Submitted: December 10, 2018
Results First Posted: February 6, 2019
Last Update Posted: July 24, 2019