Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Menstrual Cycle

February 4, 2025 updated by: Nourhan Mohamed Mitwally Amer, Cairo University

Isokinetic Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Different Phases of Menstrual Cycle

The goal of this observational study is to investigate the effect of primary dysmenorrhea on strength of hip joint muscles in females.

Study Overview

Detailed Description

The menstrual cycle is a physiological process in females manifested as periodic vaginal bleeding due to the shedding of the uterine lining (menstruation). Characterized by dynamic fluctuations in serum concentrations of several female sex steroid hormones. Estrogen, progesterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) play a critical role in regulating the precise timing and events of the ovulatory cycle. Dysmenorrhea is considered a menstrual disorder and defined as painful menstrual cramps of uterine origin. It is classified as either primary or secondary dysmenorrhea (SD). Primary dysmenorrhea (PD) constitutes a prevalent gynecological condition in the absence of any identifiable pelvic pathology, characterized by cramping and severe pain localized within the lower abdomen. The prevalence of primary dysmenorrhea in females of reproductive age ranges from 45.0% to 94.0% in countries worldwide with 2% to 29% experiencing severe pain. A greater prevalence (70% to 90%) was generally reported among younger women (<24 years). Moderate and severe dysmenorrhea has even become a major reason for absenteeism from academic and professional settings and physical activity limitation in young women. Physical activity from standing, walking and balance to high impact sports was found to be directly influenced by the strength, power, and endurance of lower limb (LL) muscles especially hip muscles. Previous studies showed that the strength of LL muscles is influenced by the hormonal fluctuation that occurs during menstrual cycle phases.

These trial participants; will be divided into two groups:

(Group A): Female with symptomatic PD according to WaLLID scale. (Group B): Female with asymptomatic PD according to WaLLID scale.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt, 12511
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

44 adult females , age range: 20-25 years , BMI: 18-25 , 22 participants have symptomatic primary dysmenorrhea and 22 have asymptomatic primary dysmenorrhea according WaLLID Questionnaire

Description

Inclusion Criteria:

  • Age range from 20 to 25 years.
  • BMI ranges from 20 to 25 kg/m2.
  • Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding).
  • No pathology related to the pelvis.
  • Having no injury in the lower limb.
  • Not consuming contraceptives, dietary supplements and steroid drugs.

Exclusion Criteria:

  • Menstrual irregularity.
  • Pregnancy or suspicion of pregnancy.
  • Having given birth.
  • Using an intrauterine device.
  • Oral contraceptives or antidepressant use.
  • Having a diagnosis of secondary dysmenorrhea.
  • Surgical history involving the abdominal region, pelvic region, and/or the spine in the last year.
  • Having musculoskeletal problems related to lower extremities.
  • Having any psychiatric or gynecological problems.
  • Suffering from premenstrual syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Symptomatic dysmenorrhea
According to WaLLID Scale Questionnaire

Assessment of the strength of hip flexors and extensors muscles:

  • Participants will be in a supine-lying position, the highest reliability (ICC = 0.90) according to the results of the meta-analysis (Contreras et al., 2021).
  • Seat orientation 0°.
  • Dynamometer tilt 0° and orientation 0°.
  • The axis of the dynamometer on the greater trochanter of the femur.
  • The test parameters included a 0-90 degree range of motion.
  • During the isokinetic testing movement, the hip was first flexed from a neutral (starting) position to 90° (for hip flexion) and then the direction of the movement was reversed (for hip extension)
  • Angular speed at 120°/s which shows excellent reliability (ICC = 95%) with concentric contraction mode (Contreras et al., 2021) .
Group B: Asymptomatic dysmenorrhea
According to WaLLID Scale Questionnaire

Assessment of the strength of hip flexors and extensors muscles:

  • Participants will be in a supine-lying position, the highest reliability (ICC = 0.90) according to the results of the meta-analysis (Contreras et al., 2021).
  • Seat orientation 0°.
  • Dynamometer tilt 0° and orientation 0°.
  • The axis of the dynamometer on the greater trochanter of the femur.
  • The test parameters included a 0-90 degree range of motion.
  • During the isokinetic testing movement, the hip was first flexed from a neutral (starting) position to 90° (for hip flexion) and then the direction of the movement was reversed (for hip extension)
  • Angular speed at 120°/s which shows excellent reliability (ICC = 95%) with concentric contraction mode (Contreras et al., 2021) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Hip flexors isokinetic strength 2- Hip extensors isokinetic strength
Time Frame: 3 months
The Biodex isokinetic dynamometer (System 4 pro) will be used to assess the strength of hip flexors and extensors during different phases of menstrual cycle.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nourhan Mohamed Mitwally Amer, Bachelor Physical Therapy- MUST
  • Study Chair: Amal Mohamed Yousef, Professor, Cairo University
  • Study Director: Mai Mohamed Ali, Lecturer, Cairo University
  • Study Director: Ehab Kamal Mohamed Younis, lecturer, Lecturer of obstetrics and gynecology - Faculty of Medicine - Misr university for science and technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

January 15, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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