Abdominal Muscle Strengthening for Menstrual Symptoms in Primary Dysmenorrhea

NCT ID: NCT07130292

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-13
• Study Completion Date: 2025-09-25

Brief Summary

This randomized controlled trial aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pelvic pathology, is common among women of reproductive age and can negatively affect quality of life.

In this study, 58 female participants aged 18-25 with regular menstrual cycles and a Visual Analog Scale (VAS) pain score of ≥4 will be randomly assigned to either an intervention group or a control group. The intervention group will perform abdominal strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, three times per week for 6 weeks (excluding menstruation weeks).

The main outcomes include menstrual symptom severity (assessed by the Menstrual Symptom Scale), pain intensity (VAS), and abdominal muscle strength (measured using the stabilizer pressure biofeedback device). The results will help determine whether targeted abdominal muscle training can reduce menstrual symptoms and improve muscle strength in women with primary dysmenorrhea.

Detailed Description

Primary dysmenorrhea (PD) is one of the most common gynecological problems in women of reproductive age, characterized by spasmodic cramps in the lower abdomen before or during menstruation, without pelvic pathology. The underlying pathophysiology involves increased release of prostaglandin F2α during menstruation, leading to stronger uterine contractions, reduced blood flow, hypoxia, and pain. PD often begins soon after menarche and may be accompanied by nausea, vomiting, diarrhea, fatigue, and sleep disturbances.

Conventional treatment approaches include pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives. However, these treatments may have side effects and limited patient compliance. Non-pharmacological interventions, especially exercise programs, have shown potential in reducing menstrual pain by increasing endorphin release, relaxing uterine muscles, and improving regional blood flow. Strengthening abdominal and core muscles can improve pelvic stability and potentially reduce dysmenorrhea symptoms.

The stabilizer pressure biofeedback unit is a simple, non-invasive device that provides visual feedback during muscle activation, helping to target deep stabilizing muscles such as the transversus abdominis. By enhancing activation capacity, it may improve abdominal muscle strength and reduce menstrual symptoms.

Study Design:

This is a randomized, controlled, single-blind trial. Fifty-eight eligible women aged 18-25 with regular menstrual cycles, a VAS score ≥4, and no diagnosis of secondary dysmenorrhea or other gynecological disorders will be enrolled. Participants will be allocated to the intervention or control group using permuted block randomization. Assessments will be conducted three times: at baseline (first day of the menstrual cycle), mid-intervention (week 3-4), and post-intervention (week 8).

Intervention:

The intervention group will perform a structured exercise program targeting the lumbar and abdominal muscles, supervised three times per week for 6 weeks (excluding menstruation weeks). Exercises will include stretching, mobility, and strengthening activities, with abdominal muscle training guided by a stabilizer pressure biofeedback device. The control group will not receive this intervention during the study period.

Outcome Measures:

Primary outcomes: Menstrual symptom severity (Menstrual Symptom Scale), pain intensity (VAS).

Secondary outcome: Abdominal muscle strength (stabilizer pressure biofeedback).

Significance:

This study will provide evidence on whether non-pharmacological abdominal muscle strengthening using stabilizer pressure biofeedback can reduce menstrual symptoms and improve muscle strength in young women with primary dysmenorrhea. The findings may guide future exercise-based interventions for menstrual pain management.

Conditions

Menstrual Pain; Menstrual Disorders; Muscle Strength

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback

Participants perform a structured exercise program targeting lumbar and abdominal muscles, guided by a stabilizer pressure biofeedback device. Sessions are supervised three times per week for 6 weeks (excluding menstruation weeks) and include mobility, stretching, and strengthening exercises to improve abdominal muscle activation and core stability.

Group Type: EXPERIMENTAL

Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback

Intervention Type: BEHAVIORAL

A supervised exercise program designed to strengthen abdominal and lumbar muscles, incorporating the use of a stabilizer pressure biofeedback device to enhance activation of deep stabilizing muscles such as the transversus abdominis. The program is delivered three times per week for 6 weeks (excluding menstruation weeks) and includes mobility, stretching, and strengthening exercises.

Control - No Abdominal Muscle Strengthening Intervention

Participants receive no abdominal muscle strengthening program during the study period. They continue their usual daily activities without any supervised exercise intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback

A supervised exercise program designed to strengthen abdominal and lumbar muscles, incorporating the use of a stabilizer pressure biofeedback device to enhance activation of deep stabilizing muscles such as the transversus abdominis. The program is delivered three times per week for 6 weeks (excluding menstruation weeks) and includes mobility, stretching, and strengthening exercises.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female participants aged 18-25 years
• Regular menstrual cycles
• Diagnosed with primary dysmenorrhea (no secondary dysmenorrhea or other gynecological disorders)
• Menstrual pain intensity ≥ 4 on the Visual Analog Scale (VAS) during the menstrual cycle
• Willingness to participate and ability to provide informed consent

Exclusion Criteria

• Diagnosis of secondary dysmenorrhea or other gynecological disorders (e.g., endometriosis, adenomyosis, uterine fibroids)
• Current pregnancy or breastfeeding
• History of abdominal or pelvic surgery in the past 6 months
• Current use of hormonal therapy or analgesic medication that could affect menstrual pain assessment
• Participation in regular abdominal or core strengthening exercise programs within the last 3 months
• Any musculoskeletal, neurological, or systemic condition that could interfere with exercise performance or study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bulent Ecevit University

OTHER

Sponsor Role: lead

Responsible Party

Sanem ŞENER

Assistant Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assistant Professor of Physiotherapy

Role: PRINCIPAL_INVESTIGATOR

Zonguldak Bulent Ecevit University

Central Contacts

Sanem ŞENER

Role: CONTACT

sanemsener@yahoo.com

+90 553-591-83-96

Other Identifiers

ZBEU-SPB-PD-2025-01

Identifier Type: -

Identifier Source: org_study_id