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Pelvic Floor Muscle Activity in Primary Dysmenorrhea

NCT ID: NCT06803173

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-04-15

Brief Summary

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This study will be conducted to assess the pelvic floor muscle (PFM) activity in primary dysmenorrhea (PD).

Detailed Description

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Dysmenorrhea, marked by painful menstrual cramps, often involves increased PFM tension, spasms, and inflammation, affecting females' quality of life and productivity. The traditional focus has been on investigating the abdominal region in women with PD. However, this new perspective considers that the hormonal changes experienced during the menstrual cycle in PD patients may lead to a heightened sensitivity of the PFM, not just the abdominal area. This suggests that the pain associated with PD may have a more widespread impact on the pelvic region rather than being localized to the abdomen. Pelvic floor myofascial trigger points (MTrPs) may also exacerbate menstrual pain through the neural pathway.

There is a critical gap in the literature regarding the nature of the association between dysmenorrhea and PFM activity in this population. Yet, it is unknown whether the pain is a cause or result of increased PFM tone, and the nature of the association between menstrual pain and PFM tone in women with PD is also unknown.

So, this study utilizes transabdominal ultrasound (TAU) to examine PFM activity in PD, aiming to clarify how PFM activity contributes to menstrual pain. Understanding these dynamics could lead to preventive strategies and educational efforts highlighting the role of pelvic floor interventions in managing dysmenorrhea, potentially improving treatment methods and overall women's health management.

Conditions

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Primary Dysmenorrhea

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group of mild primary dysmenorrhea

It will consist of 26 females with mild dysmenorrhea (WaLIDD score =1-4)

No intervention

Intervention Type OTHER

No intervention

group of moderate primary dysmenorrhea

It will consist of 26 females with moderate dysmenorrhea (WaLIDD score =5-7)

No intervention

Intervention Type OTHER

No intervention

group of severe primary dysmenorrhea

It will consist of 26 females with severe dysmenorrhea (WaLIDD score =8-12)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* They should be virgin, healthy female physiotherapy students with PD.
* They have regular menstruation (3-8 days in duration, with 21-35 days in between).
* Their ages will range from 18 to 25 years old.
* Their body mass index (BMI) will range from 18 to 24.9 kg/m2.
* Their waist-to-hip ratio will be less than 0.8.

Exclusion Criteria

* Any urological or gynecological disorders in the previous 12 weeks (e.g., endometriosis, fibroids).
* Fibromyalgia.
* Severe psychiatric or psychological disorders.
* Those who had taken analgesics in the 12 hours before the assessment.
* Abdominal or pelvic surgery within the past six months.
Minimum Eligible Age

19 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Wafaa Abdelraouf Mohamed Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa A. Osman, PhD

Role: STUDY_CHAIR

Assistant Professor

Hossam A. Al Din Hussein Kamel, PhD

Role: STUDY_DIRECTOR

Professor

Locations

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Cairo University

Giza, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Wafaa AM Abdelraouf, B.Sc.

Role: CONTACT

Phone: 01021080497

Email: [email protected]

Amira Nagy Abdellatif, PhD

Role: CONTACT

Facility Contacts

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Wafaa AM Abdelraouf Mohamed, B.Sc.

Role: primary

Amira Nagy Abdellatif, PhD

Role: backup

Other Identifiers

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P.T.REC/012/005371

Identifier Type: -

Identifier Source: org_study_id