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Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea

2026年6月8日 更新者：Vrije Universiteit Brussel

Effects of Physiotherapy on Ultrasound and Clinical Parameters in Women With Dysmenorrhea With or Without Endometriosis

Dysmenorrhea affects up to 90% of women of reproductive age and represents a significant public health concern. Beyond prostaglandin-mediated uterine contractions, dysmenorrhea involves central sensitization mechanisms and myofascial components, including abdominal trigger points. Despite growing interest in physiotherapy for chronic pelvic pain, objective data on tissue-level changes induced by manual therapy remain scarce.

This randomized single-blind sham-controlled trial aims to evaluate the effects of abdominal manual mobilization techniques on (1) tissue stiffness measured by shear wave elastography at the uterine cervix and bilateral abdominal regions, and (2) clinical outcomes including pain intensity and quality of life in women with dysmenorrhea, with or without endometriosis.

Participants will be randomly assigned to either a treatment group receiving standardized abdominal manual therapy or a sham group receiving superficial manual contact. Assessments will be conducted over three menstrual cycles using shear wave elastography, the Numeric Rating Scale (NRS), and the SF-36 questionnaire.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Women aged 18 to 50 years with dysmenorrhea will be recruited across two sites in Brussels, Belgium. At baseline (T0), participants will complete questionnaires (SF-36, NRS) and undergo transabdominal shear wave elastography at the uterine cervix and at bilateral peri-umbilical points at three measurement depths.

The intervention consists of one session per week over three menstrual cycles. The treatment group receives standardized abdominal manual mobilization techniques. The sham group receives superficial manual contact without therapeutic intent.

Outcomes are assessed at T0 (baseline), T2 (immediately after first intervention), T3 (end of cycle 2), and T4 (end of cycle 3).

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

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。

学习联系方式

研究联系人备份

  • 姓名：Steven Provyn, PhD
  • 电话号码：+32475454214

学习地点

  • 比利时
    • Brussels Capital
      • Brussels、Brussels Capital、比利时、1090
      • Brussels、Brussels Capital、比利时、1160

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

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • female sex
  • aged 18 to 50 years
  • clinical diagnosis of dysmenorrhea (cyclic pelvic pain during menstruation)

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Delivery less than 1 year prior to enrollment
  • History of abdominal or pelvic surgery within the past 3 months
  • Diagnosis of fibromyalgia, diabetes, or cancer
  • Ongoing manual therapy treatment of the abdominal or genital area

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Manual Abdominal Mobilization
Participants receive standardized abdominal manual mobilization techniques applied by a physiotherapist, once per week over three menstrual cycles. Session duration: 20 min
程序：Abdominal manual mobilization

Abdominal mobilization (10 min): Patient supine, knees flexed. Therapist's ulnar hand borders placed on lower abdomen. During expiration, a cranial manual push is applied following the respiratory cycle; the maneuver is repeated during inspiration. Hands are then placed over the lower ribs at the diaphragmatic domes; a caudal push is applied during inspiration and repeated during expiration.

Broad ligament mobilization (5 min): Patient supine, knees flexed. Therapist's cephalad hand placed over broad ligament landmarks; other hand holds the patient's legs. Opposing hand movements create an abdominal stretch. Lateral uterine mobilizations performed abdominally on both sides.

Hypopressive abdominal exercises (5 min): Therapist guides patient through hypopressive technique: exhale, breath-hold, false thoracic inspiration, abdominal draw-in, transverse abdominis contraction. Hold 10 seconds, then release. Position: standing, knees flexed, hands pressing on thighs.
假比较器：Sham Manual Therapy
Participants receive superficial manual contact in the same anatomical regions without therapeutic intent or pressure, once per week over three menstrual cycles. Session duration matches the experimental group.
程序：Sham manual contact
Superficial skin contact applied to the abdominal region without therapeutic pressure or mobilization, intended to mimic the experimental intervention in terms of time and positioning.

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
Change in uterine cervix tissue stiffness measured by shear wave elastography
大体时间：Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Transabdominal shear wave elastography of the uterine cervix. Stiffness values expressed in kilopascals (kPa) and/or meters per second (m/s).
Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Change in abdominal tissue stiffness measured by shear wave elastography
大体时间：Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Bilateral transabdominal shear wave elastography at 4 cm left and right of the umbilicus, at three depths: rectus abdominis (~1-3 cm), deep fascia (~2-4 cm), and uterine depth.
Baseline (Day 0), immediately after first session (Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.

次要结果测量

结果测量
措施说明
大体时间
Change in pain intensity during menstruation
大体时间：Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Pain will be assessed using a numerical pain scale (ranging from 0 = no pain to 10 = the worst pain imaginable).
Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Change in health-related quality of life
大体时间：Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
SF-36 Short Form questionnaire (0-100 scale, higher scores = better quality of life)
Baseline (Day 0, Cycle 1), end of cycle 2 (Cycle 2), end of cycle 3 (Cycle 3). Each cycle lasts between 28 and 31 days.
Intra- and inter-rater reliability of shear wave elastography measurements
大体时间：Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.
Reliability of transabdominal shear wave elastography measurements will be assessed at the uterine cervix and bilateral abdominal regions. Intra-rater reliability will be evaluated by repeating measurements within the same session with repositioning. Inter-rater reliability will be assessed by two independent assessors blinded to each other's results.
Baseline (Day 0 - Cycle 1). Each cycle lasts between 28 and 31 days.

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。

赞助

Vrije Universiteit Brussel

调查人员

  • 学习椅：Steven Provyn, PhD、Vrije Universiteit Brussel
  • 学习椅：Bart Roelands, PhD、Vrije Universiteit Brussel

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 (估计的)

2026年9月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26169_DYS ECHO

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data underlying the results reported in the published article will be available after de-identification (text, tables, figures and appendices). Data will be available to researchers who provide a methodologically sound proposal, beginning 6 months after publication and ending 5 years after publication. Requests should be directed to the principal investigator. Data requestors will need to sign a data access agreement.

IPD 共享时间框架

Start date: Beginning 6 months after publication of the main results. End date: Ending 5 years after publication of the main results

IPD 共享访问标准

Data will be available to researchers who submit a methodologically sound proposal. Requests should be directed to the principal investigator at the Vrije Universiteit Brussel. Data requestors will need to sign a data access agreement prior to receiving any data. All shared data will be de-identified to ensure participant confidentiality.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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