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NCT Number: NCT07702214

Relationship Between Primary Dysmenorrhea and Biomechanical Characteristics of Lumbo-pelvic Region Among Female University Students

this study will be conducted to Investigate the relationship between primary dysmenorrhea and biomechanical characteristics of lumbo-pelvic region among female university students

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Key information

Age range

18 year–24 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Females with primary dysmenorrhea

Other

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

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Hassanein, master

CONTACT

[email protected]

01158146046

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: DM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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