Clinical trial NCT06615037: Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Menstrual Cycle
Official title: Isokinetic Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Different Phases of Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Dysmenorrhea
Keywords: Dysmenorrhea
primary dysmenorrhea
Hip joint strength
isokinetic strength profile
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

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 (\&amp;lt;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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1- Hip flexors isokinetic strength 2- Hip extensors isokinetic strength
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Bachelor Physical Therapy- MUST
name: Nourhan Mohamed Mitwally Amer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Amal Mohamed Yousef, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Mai Mohamed Ali, Lecturer
role: STUDY_DIRECTOR
affiliation: Lecturer of obstetrics and gynecology - Faculty of Medicine - Misr university for science and technology
name: Ehab Kamal Mohamed Younis, lecturer
role: STUDY_DIRECTOR
References: