A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Onabotulinumtoxin A (Drug)
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).
干预措施: Kenalog (Drug)
结局指标
主要结局
Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.
时间窗: 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).
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.
时间窗: 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.
Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).
时间窗: 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.
Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.
时间窗: 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.
次要结局
- Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.(Baseline and Three Months)
- Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.(Baseline and Six Months)
- Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.(Baseline and Six months)
- Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.(Baseline and Six Months)
- Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.(Baseline and Six Months)
研究者
Jamie Bartley, DO
Principal Investigator
William Beaumont Hospitals