Dysmenorrhea PrimaryDMNCT07702214
Relationship Between Primary Dysmenorrhea and Biomechanical Characteristics of Lumbo-pelvic Region Among Female University Students
An observational study of Dysmenorrhea Primary, run by Cairo University.
Trial summary
this study will be conducted to Investigate the relationship between primary dysmenorrhea and biomechanical characteristics of lumbo-pelvic region among female university students Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Females with primary dysmenorrhea and Females without dysmenorrhea
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 24 years
- Women only
- No healthy volunteers
- Adult
Study population: 128 female university students aged 18-24 years with a Body Mass Index (BMI) between 18.5 and 24.9 kg/m² will participate in this study. The female will be allocated to groups depending on the level of NRS, more than 4 will be in the dysmenorrhea group, and less than 3 will be in the non-dysmenorrhea group.
Who may be able to join
- Female university students aged 18-24 years
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Regular menstrual cycle (28-35 days) for at least the past six months
- Willingness to avoid analgesics 72 hours prior to testing
Who cannot join
- History of pelvic or gynecological disorders
- Previous spinal, abdominal, or lower limb surgery
- Neurological disorders
- Structural spinal deformities (e.g., moderate to severe scoliosis)
- Obesity (BMI ≥ 30 kg/m²)
- Current use of oral contraceptive pills
- History of pregnancy or delivery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to Investigate the relationship between primary dysmenorrhea and biomechanical characteristics of lumbo-pelvic region among female university students
Read the detailed description
Dysmenorrhea is a highly prevalent menstrual health problem among female university students and represents a significant under recognized women's health issue. Cultural perceptions that normalize menstrual pain often result in underreporting, delayed healthcare seeking, and inadequate management among young women. This study is significant in addressing dysmenorrhea as a health condition that affects the physical, psychological, academic, and social well-being of female university students. From a physical health perspective, dysmenorrhea can lead to reduced mobility, fatigue, sleep disturbances, and musculoskeletal pain, particularly in the lumbopelvic region. Psychologically, recurrent menstrual pain may contribute to increased stress, anxiety, emotional distress, and reduced concentration. In the demanding academic environment of universities, these factors can negatively influence academic performance and mental well-being. Socially and academically, dysmenorrhea is a leading cause of class absenteeism, decreased lecture attendance, and reduced participation in practical and clinical sessions among female students.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Females with primary dysmenorrhea, Females without dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Biomechanical Characteristics, Lumbo-pelvic Region, Female University Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Females with primary dysmenorrheaOther
Female university students aged 18-24 years, Body Mass Index (BMI) between 18.5 and 24.9 kg/m² with primary dysmenorrhea (NRS > 4).
Females without dysmenorrheaOther
Female university students aged 18-24 years, with a Body Mass Index (BMI) between 18.5 and 24.9 kg/m² without dysmenorrhea (NRS less 3).
| Study group | Role | What they receive |
|---|---|---|
| Females with primary dysmenorrhea | 64 females with primary dysmenorrhea will participate in this group, neumerical rating scale more than 4. Receives: Other: Females with primary dysmenorrhea | |
| Females without dysmenorrhea | 64 females without dysmenorrhea will participate in this group. neumerical rating scale less than 3 Receives: Other: Females without dysmenorrhea |
What is being measured
The primary outcome is the main question the study is designed to answer.
life disability
The WaLIDD score (Working ability, Location, Intensity, and Days of pain) is a clinical questionnaire used to evaluate the severity of dysmenorrhea (painful menstruation) and to predict the likelihood of a person needing medical leave. It evaluates the condition using four criteria, each scored from 0 to 3, yielding a total possible score ranging from 0 to 12 points.Low/Mild Score (0 to 4 points): Indicates no dysmenorrhea.Moderate Score (5 to 7 points): Indicates moderate dysmenorrhea.High Score (8 to 12 points): Indicates severe dysmenorrhea.
Measured: up to one day
Secondary outcomes (8)
pain intensity
Pain intensity will be assessed using the Numerical Rating Scale (NRS), where participants rate their pain from 0 (no pain) to 10 (worst imaginable pain)
Measured: up to one day
pelvic tilt angle
Pelvic tilt angle will be measured using a digital pelvic inclinometer by assessing the angle between the ASIS and PSIS landmarks in a standing position
Measured: up to one day
muscle activity
The pressure biofeedback unit will be used to assess muscle activity.Subjects were asked to stand upright with pelvis and spine in neutral position and wear a lumbar support belt firmly around the abdomen. The anterior superior iliac spines (ASIS) of both sides were palpated and marked. The pressure bag was placed underneath the lumbar support one inch above the ASIS over the transversus abdominis muscle and PBU at was pumped to 70 mmHg. The participants were instructed to correctly perform abdominal drawing as much as possible and hold it for 5 seconds. For each participant 3 readings were taken, and the average of these readings was recorded.
Measured: up to one day
oscillatory frequency
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess oscillation frequency. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher oscillation frequency indicates higher muscle tone, while increased stiffness reflects greater resistance to force application.
Measured: up to one day
muscle dynamic stiffness
The MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle dynamic stiffness. it introduces an innovative and non-invasive approach for comprehensively characterizing the biomechanical and viscoelastic properties of muscles.The device is applied under constant preload (0.18 N) to pre-compress subcutaneous tissues, and it exerts a brief (15 milliseconds) mechanical tap at a pre-determined force (0.4 Newtons), followed by quick release, causing damped oscillations that are recorded by the testing probe. This device is portable, inexpensive, easy to use, and convenient for re-cording the biomechanical and viscoelastic stiffness of myofascial tissues relatively quickly.A higher dynamic stiffness indicates greater resistance to force application.
Measured: up to one day
muscle elasticity
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess muscle elasticity. it quantifies the dissipation of mechanical energy (damping) during natural oscillations of a muscle. lower values signify higher elasticity (i.e., better ability to recover from deformation), while higher values suggest lower elasticity.
Measured: up to one day
mechanical stree relaxation time
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to assess mechanical stree relaxation time with ms.It represents the duration of the muscle recovery process (or the relaxation time) from displacement.the higher tissue tension or stiffness, the faster tissue recovers its shape, meaning the lower the value.
Measured: up to one day
muscle viscoelastic property
the MyotonPro (Myoton AS Tallinn, Estonia) device will be used to viscoelastic properity. It represents the relationship between the time it takes for a tissue to undergo creep (gradual elongation) and the time it takes for it to recover or relax after being under constant deformation.Lower values: Indicate higher tissue tension, structural integrity, or increased stiffness (faster recovery).Higher values: Indicate greater viscoelasticity (slower recovery, more creep).
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Khalifa Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702214
- Sponsor's protocol ID
- P.T.REC/012/006448
- Acronym
- DM
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Primary Dysmenorrhea and Biomechanical Characteristics of Lumbo-pelvic Region Among Female University Students
- ClinicalTrials.gov ID
- NCT07702214
- Acronym / sponsor ID
- DM / P.T.REC/012/006448
- Conditions
- Dysmenorrhea Primary
- Keywords
- Primary Dysmenorrhea, Biomechanical Characteristics, Lumbo-pelvic Region, Female University Students
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (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.
this study will be conducted to Investigate the relationship between primary dysmenorrhea and biomechanical characteristics of lumbo-pelvic region among female university students
Detailed description
Dysmenorrhea is a highly prevalent menstrual health problem among female university students and represents a significant under recognized women's health issue. Cultural perceptions that normalize menstrual pain often result in underreporting, delayed healthcare seeking, and inadequate management among young women. This study is significant in addressing dysmenorrhea as a health condition that affects the physical, psychological, academic, and social well-being of female university students. From a physical health perspective, dysmenorrhea can lead to reduced mobility, fatigue, sleep disturbances, and musculoskeletal pain, particularly in the lumbopelvic region. Psychologically, recurrent menstrual pain may contribute to increased stress, anxiety, emotional distress, and reduced concentration. In the demanding academic environment of universities, these factors can negatively influence academic performance and mental well-being. Socially and academically, dysmenorrhea is a leading cause of class absenteeism, decreased lecture attendance, and reduced participation in practical and clinical sessions among female students.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females with primary dysmenorrhea | – | Other: Females with primary dysmenorrhea64 females with primary dysmenorrhea will participate in this group, neumerical rating scale more than 4. |
| Females without dysmenorrhea | – | Other: Females without dysmenorrhea64 females without dysmenorrhea will participate in this group. neumerical rating scale less than 3 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 128 female university students aged 18-24 years with a Body Mass Index (BMI) between 18.5 and 24.9 kg/m² will participate in this study. The female will be allocated to groups depending on the level of NRS, more than 4 will be in the dysmenorrhea group, and less than 3 will be in the non-dysmenorrhea group.
Key inclusion criteria (4 listed)
- Female university students aged 18-24 years
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m²
- Regular menstrual cycle (28-35 days) for at least the past six months
- Willingness to avoid analgesics 72 hours prior to testing
Key exclusion criteria (7 listed)
- History of pelvic or gynecological disorders
- Previous spinal, abdominal, or lower limb surgery
- Neurological disorders
- Structural spinal deformities (e.g., moderate to severe scoliosis)
- Obesity (BMI ≥ 30 kg/m²)
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 |
|---|---|---|
| Females with primary dysmenorrheaFemale university students aged 18-24 years, Body Mass Index (BMI) between 18.5 and 24.9 kg/m² with primary dysmenorrhea (NRS > 4). | Other | Females with primary dysmenorrhea |
| Females without dysmenorrheaFemale university students aged 18-24 years, with a Body Mass Index (BMI) between 18.5 and 24.9 kg/m² without dysmenorrhea (NRS less 3). | Other | Females without dysmenorrhea |
Primary outcome
life disability
Time frame: up to one day
The WaLIDD score (Working ability, Location, Intensity, and Days of pain) is a clinical questionnaire used to evaluate the severity of dysmenorrhea (painful menstruation) and to predict the likelihood of a person needing medical leave. It evaluates the condition using four criteria, each scored from 0 to 3, yielding a total possible score ranging from 0 to 12 points.Low/Mild Score (0 to 4 points): Indicates no dysmenorrhea.Moderate Score (5 to 7 points): Indicates moderate dysmenorrhea.High Score (8 to 12 points): Indicates severe dysmenorrhea.
8 secondary outcomes
pain intensity
Time frame: up to one day
pelvic tilt angle
Time frame: up to one day
muscle activity
Time frame: up to one day
oscillatory frequency
Time frame: up to one day
muscle dynamic stiffness
Time frame: up to one day
muscle elasticity
Time frame: up to one day
mechanical stree relaxation time
Time frame: up to one day
muscle viscoelastic property
Time frame: up to one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhea Primary, run by Cairo University.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Hassanein, master (01158146046, 4ayakhalifa4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life disability (time frame: up to one day). 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 14 Jul 2026.