- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06615037
Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Menstrual Cycle
Isokinetic Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Different Phases of Menstrual Cycle
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Giza, Egypt, 12511
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
|
|
Group B: Asymptomatic dysmenorrhea
According to WaLLID Scale Questionnaire
|
Assessment of the strength of hip flexors and extensors muscles:
|
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC\012\005318
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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