Primary DysmenorrheaNCT06615037
Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Menstrual Cycle
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this observational study is to investigate the effect of primary dysmenorrhea on strength of hip joint muscles in females. Read more about this study
- Who is it for?
- Ages 20 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)
- Keywords
- Dysmenorrhea, primary dysmenorrhea, Hip joint strength, isokinetic strength profile
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) .
| Study group | Role | What they receive |
|---|---|---|
| Group A: Symptomatic dysmenorrhea | According to WaLLID Scale Questionnaire Receives: Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro) | |
| Group B: Asymptomatic dysmenorrhea | According to WaLLID Scale Questionnaire Receives: Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Hip flexors isokinetic strength 2- Hip extensors isokinetic strength
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Mohamed Mitwally Amer, Cairo University
- Investigators
- Nourhan Mohamed Mitwally Amer, Principal investigator, Bachelor Physical Therapy- MUSTAmal Mohamed Yousef, Professor, Study chair, Cairo UniversityMai Mohamed Ali, Lecturer, Study director, Cairo UniversityEhab Kamal Mohamed Younis, lecturer, Study director, Lecturer of obstetrics and gynecology - Faculty of Medicine - Misr university for science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615037
- Sponsor's protocol ID
- P.T.REC\012\005318
- Status last verified
- Feb 2025
- First submitted
- 24 Sep 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isokinetic Strength Profile of Hip Joint in Females With Primary Dysmenorrhea During Different Phases of Menstrual Cycle
- ClinicalTrials.gov ID
- NCT06615037
- Acronym / sponsor ID
- P.T.REC\012\005318
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhea, primary dysmenorrhea, Hip joint strength, isokinetic strength profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Symptomatic dysmenorrhea | – | Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)According to WaLLID Scale Questionnaire |
| Group B: Asymptomatic dysmenorrhea | – | Other: Assess Hip joint strength by Biodex isokinetic dynamometer (System 4 Pro)According to WaLLID Scale Questionnaire |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- Menstrual irregularity.
- Pregnancy or suspicion of pregnancy.
- Having given birth.
- Using an intrauterine device.
- Oral contraceptives or antidepressant use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) . | Other | Group A: Symptomatic dysmenorrhea, Group B: Asymptomatic dysmenorrhea |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nourhan Mohamed Mitwally Amer principal investigator
Bachelor Physical Therapy- MUST
Amal Mohamed Yousef, Professor study chair
Cairo University
Mai Mohamed Ali, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Hip flexors isokinetic strength 2- Hip extensors isokinetic strength (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.