Clinical trial NCT06854900: Core Muscle Strength in Women with Primary Dysmenorrhoea
Official title: Investigation of Core Muscle Strength in Women with Primary Dysmenorrhoea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Muscle Weakness
Dysmenorrhea
Posture
Keywords: Pelvic floor
Dysmenorrhea
Posture
Core
Electromyography
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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.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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 10 minutes
measure: Menstrual Symptom Scale
timeFrame: 15 minutes
measure: Core Strength Test
timeFrame: 20 minutes
measure: Measurement of Core Muscle Strength Using Surface EMG
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bandirma
country: Turkey
facility: Derya
state: Balikesir
Study officials:
References: