ACTRN12620000067976已完成2 期
Botulinum toxin A injection into muscles of the pelvic floor as a treatment for chronic pelvic pain secondary to pelvic floor muscular spasm – A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •Female patient aged 18-45 years of age
- •Chronic pelvic pain of at least 12 months duration
- •Evidence of pelvic floor muscular spasm as assessed by the gynaecologist and pelvic floor physiotherapist – a pelvic floor pain map” will be used to aid in assessing muscle spasm and pain pre and post op and to guide injection areas.
- •Patient has had a laparoscopy and other causes of pelvic pain treated or excluded
- •Patient has had a course of conservative pelvic floor relaxation therapy with a qualified physiotherapist, patient is willing to continue this therapy post injection
- •Patient has been assessed clinically by the principal researcher or assistant researchers.
- •Patient has trialled a course of nerve modifying therapy eg amitriptyiline, gabapentin or pregabalin
排除标准
- •Patient pregnant, lactating or planning pregnancy within 6 months of injection
- •Patient has a neurological or neuromuscular conditions eg Myaesthenia gravis, Eaton Lambert syndrome, Multiple sclerosis
- •Patient not willing to return for assessment over 3 visits in the 6 months following injection of Botox
研究者
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