Primary DysmenorrheaNCT07095725
Effect of Primary Dysmenorrhea on Muscle Activity in Young Adult Females
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effect of primary dysmenorrhea on the activity of the abdominal and back muscles in young adult females. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 20 Nov 2025
- 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
- No healthy volunteers
- Adult
Study population: Young adult females with primary dysmenorrhea
Who may be able to join
- All females clinically diagnosed with PD, as confirmed and referred by a gynecologist.
- Age ranges from 18 to 25 years.
- BMI ranges from 20 to 25 kg/m2 .
- Onset of menstrual pain 6-24 months after menarche.
- Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding).
- Their PD symptoms will be determined according to the WaLLID questionnaire and will be classified into mild PD (1-4), moderate PD (5-7), severe PD (8-12).
- All participants are virgins.
Who cannot join
- Menstrual irregularity.
- Use of antidepressant or steroid drugs.
- Secondary dysmenorrhea.
- Musculoskeletal problems in the abdominal region, pelvic region, or spine.
- Surgical history involving the abdominal region, pelvic region, or spine in the last year.
- Any psychiatric or gynecological problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdelrahman Salah Sawan, Bachelor of Physical Therapy contact
Egypt1 site, 1 recruiting
- Recruiting
Misr University for Science and Technology
Giza
Mahenour Esmail Shendy, Bachelors of Physical Therapy, 01112129932, mahenour.esmail@must.edu.eg
About this study
Official title: Effect of Primary Dysmenorrhea on Abdominal and Back Muscles Activity in Young Adult Females
This study aims to investigate the effect of primary dysmenorrhea on the activity of the abdominal and back muscles in young adult females.
Read the detailed description
PD is highly prevalent in females, which directly influences their quality of life, physical function and performance. A study conducted in Palestine has shown that over half of university students with dysmenorrhea tend to skip university lectures due to painful menses.
PD is commonly associated with visceral pain and various musculoskeletal symptoms, including abdominal and back pain (Yacubovich et al., 2019). This can reduce the maximum voluntary contraction of the affected muscles, compromising their ability to provide adequate support and stability (Merkle et al., 2020). Persistent pain can disrupt postural stability and balance, raising the risk of injury by compromising stability and muscle function.
Research highlights the impact of primary dysmenorrhea (PD) on muscle function, particularly in the abdominal and back muscles, contributing to pain and reduced stability. Oladosu et al. (2018) found that abdominal muscle activity precedes menstrual pain, suggesting a neuromuscular link. Similarly, Karakus et al. (2022) and Álvarez et al. (2024) reported altered activation and reduced endurance in stabilizing muscles, including the transversus abdominis, obliques, and lumbar multifidus, with muscle thinning that may impair spinal stability. These studies emphasize PD's effect on muscle function, but further research is needed to explore variations across severities and guide effective treatments.
When these weakened muscles because of dysmenorrhea are subjected to increased or sudden activity during daily living tasks, such as lifting, bending, or other physical exertions, the risk of injury to the structures they are designed to protect is significantly heightened (Escamilla et al., 2010; Polat et al., 2022).
However, to the best of the authors' knowledge, no research has yet explored the relationship of abdominal and back muscle activity patterns to PD and their variations across different severities of dysmenorrhea, which directly contributes to females' quality of life.
Understanding this association could have significant clinical implications and contribute to new knowledge that helps physical therapists determine the need for custom-designed prevention and treatment programs for females with PD. By raising awareness of the potential musculoskeletal risks associated with PD, this study emphasizes the importance of minimizing strenuous activities during menstruation to reduce muscle strain or injury, ultimately enhancing overall health and well-being during this period.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level
- Keywords
- Muscle Activity, Maximum Voluntary Contraction, EMG, Primary Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Record EMG maximum amplitude from rectus abdominis, erector spinae L3 levelDiagnostic test
EMG Electrode Placement and Muscle Assessment:
Electrodes for the rectus abdominis were placed longitudinally at the umbilical level. For the erector spinae, L3 was located using a line between the posterior superior iliac crests, and electrodes were placed ~3 cm lateral to the L3 spinous process.
Assessment:
Rectus Abdominis: In the crook-lying position, participants performed a slow curl-up (~35-40°), holding for 10 seconds.
Erector Spinae: In the prone position with a 10-cm pad under the abdomen, participants lifted the upper body with neutral cervical alignment for 10 seconds.
Each test was repeated three times with 2-minute rest intervals.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mild dysmenorrhea | Females with mild PD, scoring (1-4) on the WaLLID scale. Receives: Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level | |
| Group B: Moderate dysmenorrhea | Females with moderate PD, scoring (5-7) on the WaLLID scale. Receives: Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level | |
| Group C: Severe dysmenorhhea | Females with severe PD, scoring (8-12) on the WaLLID scale. Receives: Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of rectus abdominis muscle
Maximum voluntary contraction in (μV) of rectus abdominis using electromyography device (EMG)
Measured: 3 months
Activity of erector spinae muscle at L3 vertebrae Level
Maximum voluntary contraction in (μV) of erector spinae at L3 Level using electromyography device (EMG)
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jul 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahenour Esmail Taha, Cairo University
- Investigators
- Mahenour Esmail Shendy, Bachelor of Physical Therapy, Principal investigator, Teaching Assistant of Physical Therapy For Women's Health- Misr University for Science and TechnologyDoaa Ahmed Osman, Assistant Professor, Study chair, Physical Therapy for Women's Health - Faculty of Physical Therapy- Cairo UniversityManal Ahmed Elshafei, Lecturer, Study director, Physical Therapy for Women's Health - Faculty of Physical Therapy- Cairo UniversityIhab Kamal Younis, lecturer, Study director, Obstetrics and Gynecology department - Faculty of Medicine Misr university for science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095725
- Sponsor's protocol ID
- P.T.REC\012\005884
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Primary Dysmenorrhea on Abdominal and Back Muscles Activity in Young Adult Females
- ClinicalTrials.gov ID
- NCT07095725
- Acronym / sponsor ID
- P.T.REC\012\005884
- Conditions
- Primary Dysmenorrhea
- Keywords
- Muscle Activity, Maximum Voluntary Contraction, EMG, Primary Dysmenorrhea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 31 Jul 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.
This study aims to investigate the effect of primary dysmenorrhea on the activity of the abdominal and back muscles in young adult females.
Detailed description
PD is highly prevalent in females, which directly influences their quality of life, physical function and performance. A study conducted in Palestine has shown that over half of university students with dysmenorrhea tend to skip university lectures due to painful menses.
PD is commonly associated with visceral pain and various musculoskeletal symptoms, including abdominal and back pain (Yacubovich et al., 2019). This can reduce the maximum voluntary contraction of the affected muscles, compromising their ability to provide adequate support and stability (Merkle et al., 2020). Persistent pain can disrupt postural stability and balance, raising the risk of injury by compromising stability and muscle function.
Research highlights the impact of primary dysmenorrhea (PD) on muscle function, particularly in the abdominal and back muscles, contributing to pain and reduced stability. Oladosu et al. (2018) found that abdominal muscle activity precedes menstrual pain, suggesting a neuromuscular link. Similarly, Karakus et al. (2022) and Álvarez et al. (2024) reported altered activation and reduced endurance in stabilizing muscles, including the transversus abdominis, obliques, and lumbar multifidus, with muscle thinning that may impair spinal stability. These studies emphasize PD's effect on muscle function, but further research is needed to explore variations across severities and guide effective treatments.
When these weakened muscles because of dysmenorrhea are subjected to increased or sudden activity during daily living tasks, such as lifting, bending, or other physical exertions, the risk of injury to the structures they are designed to protect is significantly heightened (Escamilla et al., 2010; Polat et al., 2022).
However, to the best of the authors' knowledge, no research has yet explored the relationship of abdominal and back muscle activity patterns to PD and their variations across different severities of dysmenorrhea, which directly contributes to females' quality of life.
Understanding this association could have significant clinical implications and contribute to new knowledge that helps physical therapists determine the need for custom-designed prevention and treatment programs for females with PD. By raising awareness of the potential musculoskeletal risks associated with PD, this study emphasizes the importance of minimizing strenuous activities during menstruation to reduce muscle strain or injury, ultimately enhancing overall health and well-being during this period.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Mild dysmenorrhea | – | Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 levelFemales with mild PD, scoring (1-4) on the WaLLID scale. |
| Group B: Moderate dysmenorrhea | – | Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 levelFemales with moderate PD, scoring (5-7) on the WaLLID scale. |
| Group C: Severe dysmenorhhea | – | Diagnostic Test: Record EMG maximum amplitude from rectus abdominis, erector spinae L3 levelFemales with severe PD, scoring (8-12) on the WaLLID scale. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adult females with primary dysmenorrhea
Key inclusion criteria (7 listed)
- All females clinically diagnosed with PD, as confirmed and referred by a gynecologist.
- Age ranges from 18 to 25 years.
- BMI ranges from 20 to 25 kg/m2 .
- Onset of menstrual pain 6-24 months after menarche.
- Having a regular menstrual cycle (28 ± 7 days with no intermittent bleeding).
Key exclusion criteria (6 listed)
- Menstrual irregularity.
- Use of antidepressant or steroid drugs.
- Secondary dysmenorrhea.
- Musculoskeletal problems in the abdominal region, pelvic region, or spine.
- Surgical history involving the abdominal region, pelvic region, or spine in the last year.
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 |
|---|---|---|
| Record EMG maximum amplitude from rectus abdominis, erector spinae L3 levelEMG Electrode Placement and Muscle Assessment: Electrodes for the rectus abdominis were placed longitudinally at the umbilical level. For the erector spinae, L3 was located using a line between the posterior superior iliac crests, and electrodes were placed ~3 cm lateral to the L3 spinous process. Assessment: Rectus Abdominis: In the crook-lying position, participants performed a slow curl-up (~35-40°), holding for 10 seconds. Erector Spinae: In the prone position with a 10-cm pad under the abdomen, participants lifted the upper body with neutral cervical alignment for 10 seconds. Each test was repeated three times with 2-minute rest intervals. | Diagnostic test | Group A: Mild dysmenorrhea, Group B: Moderate dysmenorrhea, Group C: Severe dysmenorhhea |
Primary outcome
Activity of rectus abdominis muscle
Time frame: 3 months
Maximum voluntary contraction in (μV) of rectus abdominis using electromyography device (EMG)
Activity of erector spinae muscle at L3 vertebrae Level
Time frame: 3 Month
Maximum voluntary contraction in (μV) of erector spinae at L3 Level using electromyography device (EMG)
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 5 Aug 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.
Abdelrahman Salah Sawan, Bachelor of Physical Therapy contact
Mahenour Esmail Shendy, Bachelor of Physical Therapy principal investigator
Teaching Assistant of Physical Therapy For Women's Health- Misr University for Science and Technology
Doaa Ahmed Osman, Assistant Professor study chair
Physical Therapy for Women's Health - Faculty of Physical Therapy- Cairo University
Manal Ahmed Elshafei, Lecturer study director
Physical Therapy for Women's Health - Faculty of Physical Therapy- 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 7 inclusion and 6 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 5 Aug 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 Mahenour Esmail Shendy, Bachelor of Physical Therapy (01112129932, mahenour.esmail@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity of rectus abdominis muscle (time frame: 3 months). The study lists 2 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 5 Aug 2025.