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The effectiveness of Botulinum toxin on persistent pelvic pain in women with endometriosis

肉毒杆菌毒素对子宫内膜异位症女性持续性盆腔疼痛的疗效

基本信息

批准号：
10915997
负责人：
Pamela Stratton
金额：
$ 1.55万
依托单位：
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10915997
关键词：
Analgesics Anxiety Botulinum Toxins Caring Case Study Clinical Trials Complex Data Data Analyses Disease Dystonia Effectiveness Elements Eligibility Determination Equipment and supply inventories Esophageal achalasia Etiology Fatigue Functional disorder Headache Health Surveys Hemifacial Spasm Human Injections Interstitial Cystitis Irritable Bowel Syndrome Measurement Measures Medical Mental Depression Muscle Muscle Contraction Myofascial Pain Syndromes Nociception Operative Surgical Procedures Pain Pathway interactions Patients Pelvic Floor Muscle Pelvic Pain Pelvic floor structure Pelvis Persistent pain Placebos Publishing Quality of life Questionnaires Randomized Recording of previous events Rome Sleep Sodium Chloride Source Spasm Standardization Time Toxin Visual Water Woman allostatic load analog botulinum neurotoxin injection central sensitization chronic pain chronic pelvic pain clinical care cohort disability effective therapy effectiveness evaluation endometriosis experience healthy volunteer improved microbial patient response placebo controlled study primary outcome secondary outcome spasticity treatment response

项目摘要

Chronic pelvic pain associated with endometriosis is poorly understood. Some women with chronic pelvic pain have muscle spasm of their pelvic muscles. Muscle spasm may be a significant part of pain in women with endometriosis and other types of chronic pelvic pain. Botulinum toxin injection is widely used to treat conditions associated with excessive muscle activity and spasm. Studies of botulinum toxin injected into pelvic muscles of women with pelvic pain have shown a decrease pain and spasm, but too few women have been studied to conclude its effectiveness. We expect to show that botulinum toxin injection in women with pelvic pain will relieve some of their pelvic pain. Eligible subjects were otherwise healthy women with chronic pelvic pain and a history of endometriosis. Subjects were randomized to either botulinum toxin injection or placebo (salt water) injection. After one month, we evaluated the presence of the pain and all women were offered botulinum toxin injection. We also evaluated the need for reinjection. The purpose of this study is to determine if botulinum toxin injections into the muscles of the pelvic floor can relieve chronic pelvic pain in women with pelvic muscle spasm. We completed the study in July 2019 with all 30 subjects completing the study; data analysis is ongoing.

慢性盆腔疼痛与子宫内膜异位症是知之甚少。一些患有慢性盆腔疼痛的女性会出现盆腔肌肉痉挛。肌肉痉挛可能是子宫内膜异位症和其他类型慢性盆腔疼痛女性疼痛的重要组成部分。肉毒杆菌毒素注射被广泛用于治疗与过度肌肉活动和痉挛相关的疾病。肉毒杆菌毒素注射到骨盆疼痛的妇女的骨盆肌肉的研究表明，减少疼痛和痉挛，但太少的妇女进行了研究，以得出其有效性。我们希望能证明肉毒杆菌毒素注射在盆腔疼痛的妇女将减轻他们的盆腔疼痛。符合条件的受试者是患有慢性盆腔疼痛和子宫内膜异位症病史的健康女性。受试者随机接受肉毒杆菌毒素注射或安慰剂（盐水）注射。一个月后，我们评估疼痛的存在，并为所有女性提供肉毒杆菌毒素注射。我们还评估了重新注入的必要性。本研究的目的是确定肉毒杆菌毒素注射到骨盆底的肌肉是否可以缓解慢性盆腔疼痛的妇女盆腔肌肉痉挛。我们于2019年7月完成了研究，所有30例受试者均完成了研究;数据分析正在进行中。