Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
研究概览
简要总结
The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
详细描述
Objective:
Primary objective: To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
Secondary objective: To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy.
Hypothesis We hypothesize that women in the Botox treatment arm, compared with those in the saline arm, will have a greater decrease in patient-reported pain on palpation of their most painful levator ani muscle group at two weeks after the injection.
To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and two weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and two-week pain measurements for the most painful muscle group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age greater than 18
- •Diagnosis of myofascial pain by an attending urogynecologist
- •Persistent pelvic pain present for ≥50% of days over the past 3 months at a level of 6 or greater on a 10-point visual analog scale
- •On physical exam, a short, tight pelvic floor with pain on palpation of at least 6 on a 10-point visual analog scale in at least one muscle group (coccygeus, pyriformis, obturator internus, iliococcygeus, puborectalis, or pubococcygeus).
- •Ability to read English, provide written, informed consent and be able and willing to go to pelvic floor physical therapy.
排除标准
- •Pregnancy or breastfeeding
- •Any of the following a pre-existing neurologic or neuromuscular condition that precludes them from Botox injections, such as myasthenia gravis, a bleeding disorder; or sensitivity or allergy to Botox
- •Current use of aminoglycosides or any other medication that may potentiate the neuromuscular weakness that could be caused by concomitant use of Botox also will be ineligible
- •History of treatment with Botox to the pelvic floor
- •Presence of any masses or lesions on physical exam
- •Pelvic organ prolapse greater than stage 2
- •Plan for pelvic floor surgery or pelvic floor physical therapy treatment in the next three months
- •Change in pain medication usage in the past 3 months
研究组 & 干预措施
Botulinum Toxin Type A
Patients in the treatment group will receive 200 Units of Botulinum toxin diluted in 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.
干预措施: Intervention-Botulinum Toxin Type A (Drug)
Saline
Patients in the placebo group will receive 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.
干预措施: placebo (Drug)
结局指标
主要结局
To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
时间窗: 2 weeks after pelvic floor injection
To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and two weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and two-week pain measurements for the most painful muscle group.
次要结局
- To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy.(12 weeks following pelvic floor injection)
研究者
Sybil Dessie, MD
Clinical Instructor
Boston Urogynecology Associates