Clinical trial NCT02369068: Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
timeFrame: Baseline and One Month
measure: 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.
timeFrame: Baseline and One Month
measure: Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
timeFrame: Baseline and One Month
measure: Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
timeFrame: Baseline and One Month
Secondary outcomes:
measure: Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
timeFrame: Baseline and Three Months
measure: 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.
timeFrame: Baseline and Three Months
measure: Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
timeFrame: Baseline and Three months
measure: Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
timeFrame: Baseline and Three Months
measure: Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.
timeFrame: Baseline and Six Months
measure: 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.
timeFrame: Baseline and Six Months
measure: Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
timeFrame: Baseline and Six months
measure: Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.
timeFrame: Baseline and Six Months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospitals
state: Michigan
Study officials:
affiliation: Beaumont
name: Jamie Bartley, DO
role: PRINCIPAL_INVESTIGATOR
References: