Pelvic Floor Muscle WeaknessNCT06854900
Core Muscle Strength in Women with Primary Dysmenorrhoea
An observational study of Pelvic Floor Muscle Weakness and Dysmenorrhea, run by Derya Azim at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without Primary Dysmenorrhea (PD). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Dysmenorrhea, Posture
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 20 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The sample size for the study was determined using the G*Power software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method. Based on similar studies, an effect size of d = 0.726 was used for the calculation. With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.
Who may be able to join
- Participants must meet the following criteria to be included in the study:
- Age between 18 and 35 years
- Diagnosed with Primary Dysmenorrhea (PD) according to the PD consensus criteria, which include:
- Presence of menstrual pain within the first few years after menarche A Visual Analog Scale (VAS) pain score of 4 or higher in the last six months No pelvic pathology Having a regular menstrual cycle (21-35 days) No uterine disorders
Who cannot join
- The sample size for the study was determined using the GPower software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).
- Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method.
- Based on similar studies, an effect size of d = 0.726 was used for the calculation.
- With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.Pregnancy or suspicion of pregnancy Active sexual life History of childbirth Use of an intrauterine device (IUD) History of surgery involving the abdomen, spine, or pelvic region within the last year Diagnosis of secondary dysmenorrhea Body mass index (BMI) of 30 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Core Muscle Strength in Women with Primary Dysmenorrhoea
The aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without Primary Dysmenorrhea (PD).
Read the detailed description
The study included 27 women with PD and 27 healthy women without primary dysmenorrhea. Demographic and menstrual information of the participants was recorded. The "Sport-Specific Core Muscle Strength \& Stability Plank Test" protocol was applied to evaluate the core muscle strength of the participants. Pelvic floor, transversus abdominis, and multifidus muscle activations were assessed using the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device. Pelvic tilt measurement was performed using the Apecs-AI Posture Assessment and Correction System®. Menstrual pain and symptoms were evaluated using the Menstrual Symptom Scale.
This study found that women with PD had higher muscle activations, lower pelvic tilt angles, and more severe menstrual symptoms. We believe these results may contribute to the etiology of PD.
- Conditions
- Pelvic Floor Muscle Weakness, Dysmenorrhea, Posture
- Keywords
- Pelvic floor, Dysmenorrhea, Posture, Core, Electromyography
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dysmenorrhea | Dysmenorrhea | |
| Healthy Woman | Healthy Woman |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
One of the most commonly used methods for determining pain intensity is the Visual Analog Scale (VAS). In addition to assessing the severity of pain, VAS also provides information about how badly the patient feels due to pain. VAS consists of a 10 cm long line drawn either on a vertical or horizontal axis. At one end of the line, the phrase "no pain" is written, while at the other end, "unbearable pain" is indicated. Patients are asked to mark the point on the line that corresponds to the intensity of their pain. The distance from the "no pain" point to the patient's mark is then measured. This measurement provides a numerical value for the patient's pain intensity:
0-2 cm: No pain 3-4 cm: Mild pain 5-6 cm: Moderate pain 7-8 cm: Severe pain 9-10 cm: Unbearable pain
Measured: 10 minutes
Menstrual Symptom Scale
Developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms, this scale was validated and tested for reliability by Güvenç et al. (2014). The scale consists of 22 items and is structured as a five-point Likert-type measure.
Items 1-13 belong to the "Negative Effects/Somatic Complaints" subscale. Items 14-19 belong to the "Menstrual Pain Symptoms" subscale. Items 20-22 belong to the "Coping Methods" subscale. The Menstrual Symptom Scale score is calculated by taking the average total score of the items. Participants are asked to rate their menstrual symptoms by selecting a number between 1 (Never) and 5 (Always). A higher average score indicates greater severity of menstrual symptoms.
Each subscale score is calculated by taking the average of the items within that subscale, and an increase in the subscale score reflects an increase in the severity of menstrual symptoms related to that specific subscale.
The Cronbach's Alpha value of the scale is 0.86, indicating a hi
Measured: 15 minutes
Core Strength Test
To assess participants' core muscle strength, the "Sport-Specific Core Muscle Strength \& Stability Plank Test" protocol will be applied. This test was developed by Brian Mackenzie and its validity and reliability were studied by Tong et al. (2013) (95%, 0.94-0.99). The test consists of 8 steps and is performed against time, with a total duration of 3 minutes.
Test Procedure:
Step 1: The athlete assumes the plank position, and the test starts using a stopwatch. The athlete must hold this position for 60 seconds.
Step 2: While maintaining the plank position, the athlete extends their right arm forward and holds it for 15 seconds.
Step 3: The athlete extends their left arm forward and holds it for 15 seconds. Step 4: The athlete lifts their right foot 30 cm off the ground and holds it for 15 seconds.
Step 5: The athlete lifts their left foot 30 cm off the ground and holds it for 15 seconds.
Step 6: The athlete lifts their right arm and left foot simultaneously and holds them for 15 seco
Measured: 20 minutes
Measurement of Core Muscle Strength Using Surface EMG
The strength of the pelvic floor, transversus abdominis, and multifidus muscles will be assessed using surface electromyography (sEMG). For this evaluation, the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device (Verity Medical Ltd., UK) will be used to measure and record muscle activation. The device connects to a computer via specialized software.
Electrode Placement and Preparation
Electrodes:
32 mm diameter, circular, adhesive silver-silver chloride (Ag-AgCl) electrodes will be used to measure muscle activity.
Each participant will be provided with three personalized electrodes for the measurement.
Skin Preparation:
To ensure optimal signal quality, the skin area where the electrodes will be applied must be clean.
Participants will be informed about preparing the application site before the measurement.
To reduce skin impedance, the area where the surface electrodes will be placed will be cleaned with an alcohol wipe before the measurement.
Electrode Placement for Pelvic Floor Musc
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 Jan 2024
- Primary completion15 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Derya Azim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Derya Azim, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854900
- Sponsor's protocol ID
- 03. 04. 2024-176
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Core Muscle Strength in Women with Primary Dysmenorrhoea
- ClinicalTrials.gov ID
- NCT06854900
- Acronym / sponsor ID
- 03. 04. 2024-176
- Conditions
- Pelvic Floor Muscle Weakness, Dysmenorrhea, Posture
- Keywords
- Pelvic floor, Dysmenorrhea, Posture, Core, Electromyography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Derya AzimUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 3 Mar 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 aim of this study is to compare core muscle strength, core muscle activations, and pelvic tilt angles in women with and without Primary Dysmenorrhea (PD).
Detailed description
The study included 27 women with PD and 27 healthy women without primary dysmenorrhea. Demographic and menstrual information of the participants was recorded. The "Sport-Specific Core Muscle Strength \& Stability Plank Test" protocol was applied to evaluate the core muscle strength of the participants. Pelvic floor, transversus abdominis, and multifidus muscle activations were assessed using the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device. Pelvic tilt measurement was performed using the Apecs-AI Posture Assessment and Correction System®. Menstrual pain and symptoms were evaluated using the Menstrual Symptom Scale.
This study found that women with PD had higher muscle activations, lower pelvic tilt angles, and more severe menstrual symptoms. We believe these results may contribute to the etiology of PD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysmenorrhea | – | –Dysmenorrhea |
| Healthy Woman | – | –Healthy Woman |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample size for the study was determined using the G*Power software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method. Based on similar studies, an effect size of d = 0.726 was used for the calculation. With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.
Key inclusion criteria (4 listed)
- Participants must meet the following criteria to be included in the study:
- Age between 18 and 35 years
- Diagnosed with Primary Dysmenorrhea (PD) according to the PD consensus criteria, which include:
- Presence of menstrual pain within the first few years after menarche A Visual Analog Scale (VAS) pain score of 4 or higher in the last six months No pelvic pathology Having a regular menstrual cycle (21-35 days) No uterine disorders
Key exclusion criteria (4 listed)
- The sample size for the study was determined using the GPower software (latest version 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).
- Since our study consists of two groups (participants with and without Primary Dysmenorrhea), the power analysis was conducted using the "Means: Difference between two independent means (two groups)" method.
- Based on similar studies, an effect size of d = 0.726 was used for the calculation.
- With a statistical power of 80% and a significance level of 5% (α = 0.05), the minimum required sample size was determined to be at least 25 participants per group, totaling 50 participants.Pregnancy or suspicion of pregnancy Active sexual life History of childbirth Use of an intrauterine device (IUD) History of surgery involving the abdomen, spine, or pelvic region within the last year Diagnosis of secondary dysmenorrhea Body mass index (BMI) of 30 or higher
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale (VAS)
Time frame: 10 minutes
One of the most commonly used methods for determining pain intensity is the Visual Analog Scale (VAS). In addition to assessing the severity of pain, VAS also provides information about how badly the patient feels due to pain. VAS consists of a 10 cm long line drawn either on a vertical or horizontal axis. At one end of the line, the phrase "no pain" is written, while at the other end, "unbearable pain" is indicated. Patients are asked to mark the point on the line that corresponds to the intensity of their pain. The distance from the "no pain" point to the patient's mark is then measured. This measurement provides a numerical value for the patient's pain intensity: 0-2 cm: No pain 3-4 cm: Mild pain 5-6 cm: Moderate pain 7-8 cm: Severe pain 9-10 cm: Unbearable pain
Menstrual Symptom Scale
Time frame: 15 minutes
Developed by Chesney and Tasto (1975) to assess menstrual pain and symptoms, this scale was validated and tested for reliability by Güvenç et al. (2014). The scale consists of 22 items and is structured as a five-point Likert-type measure. Items 1-13 belong to the "Negative Effects/Somatic Complaints" subscale. Items 14-19 belong to the "Menstrual Pain Symptoms" subscale. Items 20-22 belong to the "Coping Methods" subscale. The Menstrual Symptom Scale score is calculated by taking the average total score of the items. Participants are asked to rate their menstrual symptoms by selecting a number between 1 (Never) and 5 (Always). A higher average score indicates greater severity of menstrual symptoms. Each subscale score is calculated by taking the average of the items within that subscale, and an increase in the subscale score reflects an increase in the severity of menstrual symptoms related to that specific subscale. The Cronbach's Alpha value of the scale is 0.86, indicating a hi
Core Strength Test
Time frame: 20 minutes
To assess participants' core muscle strength, the "Sport-Specific Core Muscle Strength \& Stability Plank Test" protocol will be applied. This test was developed by Brian Mackenzie and its validity and reliability were studied by Tong et al. (2013) (95%, 0.94-0.99). The test consists of 8 steps and is performed against time, with a total duration of 3 minutes. Test Procedure: Step 1: The athlete assumes the plank position, and the test starts using a stopwatch. The athlete must hold this position for 60 seconds. Step 2: While maintaining the plank position, the athlete extends their right arm forward and holds it for 15 seconds. Step 3: The athlete extends their left arm forward and holds it for 15 seconds. Step 4: The athlete lifts their right foot 30 cm off the ground and holds it for 15 seconds. Step 5: The athlete lifts their left foot 30 cm off the ground and holds it for 15 seconds. Step 6: The athlete lifts their right arm and left foot simultaneously and holds them for 15 seco
Measurement of Core Muscle Strength Using Surface EMG
Time frame: 30 minutes
The strength of the pelvic floor, transversus abdominis, and multifidus muscles will be assessed using surface electromyography (sEMG). For this evaluation, the NeuroTrac® MyoPlus 2 dual-channel EMG ETS device (Verity Medical Ltd., UK) will be used to measure and record muscle activation. The device connects to a computer via specialized software. Electrode Placement and Preparation Electrodes: 32 mm diameter, circular, adhesive silver-silver chloride (Ag-AgCl) electrodes will be used to measure muscle activity. Each participant will be provided with three personalized electrodes for the measurement. Skin Preparation: To ensure optimal signal quality, the skin area where the electrodes will be applied must be clean. Participants will be informed about preparing the application site before the measurement. To reduce skin impedance, the area where the surface electrodes will be placed will be cleaned with an alcohol wipe before the measurement. Electrode Placement for Pelvic Floor Musc
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pelvic Floor Muscle Weakness and Dysmenorrhea, run by Derya Azim at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 10 minutes). 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 3 Mar 2025.