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Completed

NCT Number: NCT06615037

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

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

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Key information

Age range

20 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Giza, 12511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)

Other

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) .

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2024
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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