Primary DysmenorrheaNCT07239232
"Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to assess knee joint position sense, pain and dynamic balance in female with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2025to 30 Jan 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Sixty-two healthy female university students will participate in this study. They will be selected randomly from faculty of physical therapy, Cairo University.
Who may be able to join
- They should be virgin, healthy female students
- They have regular menstruation (3-8 days in duration, with 21-35 days in-between).
- They should have the same activity level mild active female.
- Their ages will range from 18 to 25 years old.
- Their body mass index (BMI) will range from 18 to 24.9 Kg/m2.
Who cannot join
- History of knee injury, surgery in the knee or spinal vertebrae.
- Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance
- Women with any cognitive deficits
- History of neuromuscular or spinal disease.
- History of pelvic pathology or any gynecological disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
EMAN B ABDUL HAMID, B.Sc, 01158876852, emanahmed2033e@gmail.com
About this study
Official title: Assessment Of Knee Joint Position Sense And Dynamic Balance IN Female With Primary Dysmenorrhea
The purpose of the study is to assess knee joint position sense, pain and dynamic balance in female with primary dysmenorrhea.
Read the detailed description
Dysmenorrhea is a common condition that typically occurs on its own rather than as a result of pelvic disease. It affects between 50% and 90% of adolescent girls and women of reproductive age and is a major reason for missed days from school or work.
Among the various menstrual disturbances observed, dysmenorrhea was notably prevalent among adolescents and significantly impacted their daily activities. Early diagnosis and awareness of menstrual issues are crucial, as they not only emphasize the need for health education initiatives but also assist in selecting suitable treatments, thereby reducing the adverse effects of these disturbances on adolescents' lives.
However, there is a significant gap in the literature about the effect of Primary dysmenorrhea on knee joint position sense, pain and dynamic balance in young adult female So this study aims to investigate this effect and provide evidence based information in the field of physical therapy.
- Conditions
- Primary Dysmenorrhea
- Being tested
- No intervention
- Keywords
- Knee, Position sense, Balance, Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic Group | They have no or mild primary dysmenorrhea. Receives: Other: No intervention | |
| Symptomatic Group | They have moderate and sever primary dysmenorrhea. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Stability Index (OSI) . Antero-posterior stability index score (APSI) . Medio lateral stability index score (MLSI) . Over all stability index score (OASI)
The Overall Stability Index (OSI) is the primary measure of dynamic postural control obtained from the balance assessment system. It reflects the standard deviation of the participant's sway from the platform's center across both the medial-lateral and anterior-posterior directions. Higher OSI values indicate greater instability and poorer balance performance. As an integrated measure of sway variability, the OSI is considered the most comprehensive indicator of overall balance ability and is commonly used to evaluate changes in postural control in response to therapeutic interventions.
Measured: at first and fourth menstrual days
Medial-Lateral Stability Index (MLSI)
The Medial-Lateral Stability Index (MLSI) quantifies the degree of side-to-side sway during balance testing. It represents the standard deviation of medial-lateral movement from the platform's center point, providing a directional measure of postural stability. Elevated MLSI scores reflect increased lateral instability, which may be associated with impaired neuromuscular control or deficits in weight-shifting ability. This variable is useful for identifying balance impairments that predominantly affect frontal plane stability.
Measured: at first and fourth menstrual days
Anterior-Posterior Stability Index (APSI)
The Anterior-Posterior Stability Index (APSI) measures front-to-back sway during dynamic balance assessment. Calculated as the standard deviation of anterior-posterior deviations from the center of the platform, the APSI provides insight into sagittal plane stability. Higher APSI values indicate greater instability and reduced capacity to control forward and backward movements. This index is important for evaluating postural control related to gait, stepping, and activities requiring controlled anterior or posterior shifts in the center of gravity.
Measured: at first and fourth menstrual days
knee joint position sense
using active knee position sense test by universal goniometer.
Measured: at first and fourth menstrual days
Secondary outcomes (1)
knee joint pain
It will be assessed using the Visual analog scale (VAS) for all females in both groups. They will score their level of pain from 1-10, with higher scores indicating more severe pain. It is valid and reliable in pain assessment
Measured: at first and fourth menstrual days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start18 Nov 2025
- Primary completion20 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Belal Ahmed, Cairo University
- Investigators
- AFAF M BOTLA, PhD, Study chair, Assistant Professor, Cairo UniversityELHAM s HASSAN, PhD, Study director, Lecturer, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239232
- Sponsor's protocol ID
- P.T.REC/012/005972
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Knee Joint Position Sense And Dynamic Balance IN Female With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07239232
- Acronym / sponsor ID
- P.T.REC/012/005972
- Conditions
- Primary Dysmenorrhea
- Keywords
- Knee, Position sense, Balance, Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 20 Nov 2025 (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 purpose of the study is to assess knee joint position sense, pain and dynamic balance in female with primary dysmenorrhea.
Detailed description
Dysmenorrhea is a common condition that typically occurs on its own rather than as a result of pelvic disease. It affects between 50% and 90% of adolescent girls and women of reproductive age and is a major reason for missed days from school or work.
Among the various menstrual disturbances observed, dysmenorrhea was notably prevalent among adolescents and significantly impacted their daily activities. Early diagnosis and awareness of menstrual issues are crucial, as they not only emphasize the need for health education initiatives but also assist in selecting suitable treatments, thereby reducing the adverse effects of these disturbances on adolescents' lives.
However, there is a significant gap in the literature about the effect of Primary dysmenorrhea on knee joint position sense, pain and dynamic balance in young adult female So this study aims to investigate this effect and provide evidence based information in the field of physical therapy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic Group | – | Other: No interventionThey have no or mild primary dysmenorrhea. |
| Symptomatic Group | – | Other: No interventionThey have moderate and sever primary dysmenorrhea. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sixty-two healthy female university students will participate in this study. They will be selected randomly from faculty of physical therapy, Cairo University.
Key inclusion criteria (5 listed)
- They should be virgin, healthy female students
- They have regular menstruation (3-8 days in duration, with 21-35 days in-between).
- They should have the same activity level mild active female.
- Their ages will range from 18 to 25 years old.
- Their body mass index (BMI) will range from 18 to 24.9 Kg/m2.
Key exclusion criteria (5 listed)
- History of knee injury, surgery in the knee or spinal vertebrae.
- Females having any vestibular problems, otitis media, labyrinthitis or any inner ear problems that affect balance
- Women with any cognitive deficits
- History of neuromuscular or spinal disease.
- History of pelvic pathology or any gynecological disease.
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 |
|---|---|---|
| No interventionNo intervention | Other | Asymptomatic Group, Symptomatic Group |
Primary outcome
Overall Stability Index (OSI) . Antero-posterior stability index score (APSI) . Medio lateral stability index score (MLSI) . Over all stability index score (OASI)
Time frame: at first and fourth menstrual days
The Overall Stability Index (OSI) is the primary measure of dynamic postural control obtained from the balance assessment system. It reflects the standard deviation of the participant's sway from the platform's center across both the medial-lateral and anterior-posterior directions. Higher OSI values indicate greater instability and poorer balance performance. As an integrated measure of sway variability, the OSI is considered the most comprehensive indicator of overall balance ability and is commonly used to evaluate changes in postural control in response to therapeutic interventions.
Medial-Lateral Stability Index (MLSI)
Time frame: at first and fourth menstrual days
The Medial-Lateral Stability Index (MLSI) quantifies the degree of side-to-side sway during balance testing. It represents the standard deviation of medial-lateral movement from the platform's center point, providing a directional measure of postural stability. Elevated MLSI scores reflect increased lateral instability, which may be associated with impaired neuromuscular control or deficits in weight-shifting ability. This variable is useful for identifying balance impairments that predominantly affect frontal plane stability.
Anterior-Posterior Stability Index (APSI)
Time frame: at first and fourth menstrual days
The Anterior-Posterior Stability Index (APSI) measures front-to-back sway during dynamic balance assessment. Calculated as the standard deviation of anterior-posterior deviations from the center of the platform, the APSI provides insight into sagittal plane stability. Higher APSI values indicate greater instability and reduced capacity to control forward and backward movements. This index is important for evaluating postural control related to gait, stepping, and activities requiring controlled anterior or posterior shifts in the center of gravity.
knee joint position sense
Time frame: at first and fourth menstrual days
using active knee position sense test by universal goniometer.
1 secondary outcome
knee joint pain
Time frame: at first and fourth menstrual days
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 12 Dec 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.
AFAF M BOTLA, PhD study chair
Assistant Professor, Cairo University
ELHAM s HASSAN, PhD study director
Lecturer, 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
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 Eman B ABDUL HAMID, B.Sc (01158876852, emanahmed2033e@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Stability Index (OSI) . Antero-posterior stability index score (APSI) . Medio lateral stability index score (MLSI) . Over all stability index score (OASI) (time frame: at first and fourth menstrual days). The study lists 4 primary outcomes in all. 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 12 Dec 2025.