Core Muscle Strength in Women with Primary Dysmenorrhoea

NCT06854900 | Completed DMC

• 1 other identifier: 03. 04. 2024-176
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Pelvic Floor Muscle Weakness; Dysmenorrhea; Posture

Keywords

Pelvic floor; Dysmenorrhea; Posture; Core; Electromyography

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  30 minutes

Study Arms (2)

Dysmenorrhea

Dysmenorrhea

Healthy Woman

Healthy Woman

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derya Azim: lead

Study Sites (1)

Derya

Bandırma, Balıkesir, 34900, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: January 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 20, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)