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

NCT ID: NCT06615037

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-01-15

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 (<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.

Conditions

Primary Dysmenorrhea

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: Symptomatic dysmenorrhea

According to WaLLID Scale Questionnaire

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

Intervention Type: 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) .

Group B: Asymptomatic dysmenorrhea

According to WaLLID Scale Questionnaire

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

Intervention Type: 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) .

Interventions

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

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) .

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Mohamed Mitwally Amer

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nourhan Mohamed Mitwally Amer

Role: PRINCIPAL_INVESTIGATOR

Bachelor Physical Therapy- MUST

Amal Mohamed Yousef, Professor

Role: STUDY_CHAIR

Cairo University

Mai Mohamed Ali, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Ehab Kamal Mohamed Younis, lecturer

Role: STUDY_DIRECTOR

Lecturer of obstetrics and gynecology - Faculty of Medicine - Misr university for science and technology

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC\012\005318

Identifier Type: -

Identifier Source: org_study_id