女性慢性重叠性盆腔疼痛的肌肉骨骼和盆底健康
2026年8月27日 更新者:Colleen M. Fitzgerald, MD, MS、Loyola University
女性慢性重叠性盆腔疼痛的肌肉骨骼和盆底健康(MSK-PELVIC 研究)
本研究的目的是了解神经功能和骨盆肌肉功能。
为此,我们将比较患有慢性盆腔疼痛的女性与没有慢性盆腔疼痛的女性的盆腔神经和肌肉功能。
了解疼痛可能会导致未来更好的治疗。
研究概览
详细说明
慢性盆腔疼痛 (CPP) 可能影响多达四分之一的女性。
传统上,CPP 被认为是由内脏疼痛机制驱动的,例如间质性膀胱炎/膀胱疼痛综合征 (IC/PBS)、肠易激综合征 (IBS) 和子宫内膜异位症。
还确定这些内脏疼痛状况与外阴痛、纤维肌痛、抑郁和焦虑重叠。
最近,潜在的盆底肌筋膜 (PFMP) 和协同失调已被确定为额外的重叠 CPP 病症。
先前的工作表明 PFMP 可能是一种内脏躯体反应,但是,PFMP 作为其他区域肌肉骨骼 (MSK) 条件的补偿性结果也被提出。
事实上,在整个生命周期中,女性比男性面临更多的 MSK 损伤和慢性 MSK 病症的风险,包括运动相关损伤、关节过度活动、纤维肌痛、骨关节炎病症(绝经后)和骨质疏松症/骨质疏松症的患病率增加-相关骨折。
这些升高的风险被认为是由于独特的解剖(结构)、生物力学和激素因素造成的,这些因素可归因于怀孕和衰老的生理过程。
当前的应用程序旨在解决关于 CPP 中 PFM 的神经肌肉功能的有限理解以及可能影响 PFM 响应的重叠 MSK 条件和 MSK 健康的作用的重大知识差距。
短期目标是通过与无症状对照相比,确定患有各种重叠诊断的 CPP 女性的最精确肌肉测量值,以及评估整体 MSK 健康/身体活动,来检查 PFM 生物力学。
长期目标是确定 MSK 骨盆疼痛机制,为临床相关分类提供信息,为患有 CPP 的女性开发基于证据的非药物(物理疗法/运动)治疗,并推进 PFM 功能和 CPP 领域的研究工具因为它与 MSK 斯隆的整体健康有关。
我们的创新策略结合了神经肌肉测量,使用新型设备和经过验证的测量来评估 CPP、MSK 健康和身体活动。
我们的中心假设是,患有 CPP 的女性将表现出与无症状对照不同的可量化 PFM 异常和临床 MSK 特征。
这项研究的结果将对公共健康产生重大影响,其严谨客观和全面的 PFM 和 MSK 方法将适用于未来的 NIH 临床研究网络/试验,以评估和评估女性的 MSK 贡献和潜在治疗结果与 CPP。
研究类型
观察性的
注册 (实际的)
98
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Illinois
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Maywood、Illinois、美国、60153
- Loyola Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 80年 (成人、年长者)
接受健康志愿者
不
取样方法
非概率样本
研究人群
参与者选自三级医疗中心
描述
纳入标准:
- 女性性别
- 年龄 21 至 80 岁
- 美国妇产科学院 (ACOG) 定义的 CPP 症状持续 6 个月以上
- 七种重叠 CPP 诊断中的至少两种(即 IC/PBS、IBS、子宫内膜异位症、外阴痛、PN、FM、PFMP)
- 在 10 点疼痛量表上平均 CPP 疼痛评分至少为 3
排除标准:
- GI 或 GU 盆腔癌的当前或病史
- 当前的盆腔感染(例如 UTI 或阴道感染)
- 最近 6 个月内当前或即将怀孕或最近分娩
- 在过去 36 个月内进行过腹部或盆腔手术。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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案例
病例是诊断为盆底疾病的成年女性患者。
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音调是体格检查中盆底肌肉的二元测量
压痛是体检时盆底肌肉的二元测量
收缩是体格检查中盆底肌肉的二元测量
放松是体格检查中盆底肌肉的二元测量
肌电图是以微伏为单位测量骨盆底肌肉
使用超声波对盆底肌肉进行经会阴测量(以毫米为单位)
使用海藻计测量盆底肌肉的压力(以毫米为单位)
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控件
对照组是从门诊初级保健中心抽取的成年女性患者
|
音调是体格检查中盆底肌肉的二元测量
压痛是体检时盆底肌肉的二元测量
收缩是体格检查中盆底肌肉的二元测量
放松是体格检查中盆底肌肉的二元测量
肌电图是以微伏为单位测量骨盆底肌肉
使用超声波对盆底肌肉进行经会阴测量(以毫米为单位)
使用海藻计测量盆底肌肉的压力(以毫米为单位)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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两个受试者工作特征曲线的差异
大体时间:0 天
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两个诊断准确性统计数据(c 统计数据)之间的增量值将与其 95% 置信区间和显着性值(p 值)一起报告。
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0 天
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Colleen Fitzgerald, MD、Loyola Medical Center
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年1月24日
初级完成 (实际的)
2025年9月12日
研究完成 (实际的)
2025年9月12日
研究注册日期
首次提交
2023年1月20日
首先提交符合 QC 标准的
2023年2月20日
首次发布 (实际的)
2023年3月1日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
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