Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

Pelvic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369068
• Other study ID #: 2015-008
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 24, 2018

Study information

• Verified date: July 2019
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 24, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

Drug:
• Onabotulinumtoxin A
Intravaginal pelvic floor injection one series
• Kenalog
Intravaginal pelvic floor injection one series

Locations

Country	Name	City	State
United States	Beaumont Hospitals	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Jamie Bartley, DO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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