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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Females with primary dysmenorrhea
64 females with primary dysmenorrhea will participate in this group, neumerical rating scale more than 4.
Other: Females with primary dysmenorrhea
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
Other: Females without dysmenorrhea
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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