- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07702214
Relationship Between Primary Dysmenorrhea and Biomechanical Characteristics of Lumbo-pelvic Region Among Female University Students (DM)
July 9, 2026 updated by: Aya Khalifa Mohamed, Cairo University
this study will be conducted to Investigate the relationship between primary dysmenorrhea and biomechanical characteristics of lumbo-pelvic region among female university students
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
128
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya Hassanein, master
- Phone Number: 01158146046
- Email: 4ayakhalifa4@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Females with primary dysmenorrhea
64 females with primary dysmenorrhea will participate in this group, neumerical rating scale more than 4.
|
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 dysmenorrhea
64 females without dysmenorrhea will participate in this group.
neumerical rating scale less than 3
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oscillatory frequency
Time Frame: up to one day
|
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.
|
up to one day
|
|
muscle dynamic stiffness
Time Frame: up to one day
|
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.
|
up to one day
|
|
muscle elasticity
Time Frame: up to one day
|
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.
|
up to one day
|
|
mechanical stree relaxation time
Time Frame: up to one day
|
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.
|
up to one day
|
|
muscle viscoelastic property
Time Frame: up to one day
|
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).
|
up to one day
|
|
pain intensity
Time Frame: up to one day
|
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)
|
up to one day
|
|
pelvic tilt angle
Time Frame: up to one day
|
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
|
up to one day
|
|
muscle activity
Time Frame: up to one day
|
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.
|
up to one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 30, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
July 9, 2026
First Submitted That Met QC Criteria
July 9, 2026
First Posted (Actual)
July 14, 2026
Study Record Updates
Last Update Posted (Actual)
July 14, 2026
Last Update Submitted That Met QC Criteria
July 9, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/006448
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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