High-Density Surface Electromyography Guided Precision Botulinum Neurotoxin Injections to Manage Chronic Pelvic Floor Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
研究概览
简要总结
The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females between 18 and 75 years of age
- •Clinical diagnosis of chronic pelvic pain
- •Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) *
- •Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers
- •Pelvic muscle tenderness by assessment of pelvic floor muscles on digital pelvic examination
- •No botulinum neurotoxin pelvic floor muscle injection treatment within 6 months prior to recruitment
- •Able to provide informed consent
排除标准
- •Women < 18 and > 76 years of age
- •History of pelvic malignancy and sexual transmitted diseases that is currently not in remission
- •Bleeding disorder such as coagulopathy
- •Hypersensitivity to botulinum neurotoxin
- •Received botulinum neurotoxin pelvic floor muscle injection within 6 months prior to recruitment
- •History of neurological disorders, such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis or myasthenia gravis
- •Pregnancy, breast feeding or planning to get pregnant within one year after the last botulinum neurotoxin injection.
研究组 & 干预措施
Group A: Standard injection template followed by HD-sEMG guided injection
Participants will be in this group for up to 15 months
干预措施: Botulinum neurotoxin (Drug)
Group A: Standard injection template followed by HD-sEMG guided injection
Participants will be in this group for up to 15 months
干预措施: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device (Device)
Group B: HD-sEMG guided injection followed by standard injection template
Participants will be in this group for up to 15 months
干预措施: Botulinum neurotoxin (Drug)
Group B: HD-sEMG guided injection followed by standard injection template
Participants will be in this group for up to 15 months
干预措施: High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device (Device)
结局指标
主要结局
Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)
时间窗: 1 month post-injection
The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.
次要结局
- Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)(Baseline, 1 month post-injection)
- Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)(Baseline, 1 month post-injection)
- Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index(Baseline, 1 month post-injection)
研究者
Yingchun Zhang
Professor
University of Miami