Abdominal Muscle Strengthening for Menstrual Symptoms in Primary Dysmenorrhea

NCT07130292 | Not Yet Recruiting

• 1 other identifier: ZBEU-SPB-PD-2025-01
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Menstrual Pain; Menstrual Disorders; Muscle Strength

Keywords

Primary Dysmenorrhea; Abdominal Muscle Strengthening; Stabilizer Pressure Biofeedback

Outcome Measures

Primary Outcomes (3)

• Menstrual Symptom Severity

  Change in menstrual symptom severity as assessed by the Menstrual Symptom Scale (MSS). The MSS consists of 22 items scored on a 5-point Likert scale, with higher scores indicating more severe symptoms.

  Change from Baseline (Week 0) to Post-intervention (Week 8)

• Pain Intensity

  Visual Analog Scale 0-10 cm (0 = no pain, 10 = worst pain). Outcome is mean change from baseline to Week 8.

  Change from Baseline (Week 0) to Post-intervention (Week 8)

• Abdominal Muscle Activation/Strength (Pressure Biofeedback)

  Abdominal muscle activation measured with a Stabilizer Pressure Biofeedback Unit (mmHg). Lower pressure during correct drawing-in reflects better transversus abdominis activation. Outcome is change from baseline to Week 8

  Change from Baseline (Week 0) to Post-intervention (Week 8)

Study Arms (2)

Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback

EXPERIMENTAL

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.

Behavioral: Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback

Control - No Abdominal Muscle Strengthening Intervention

NO INTERVENTION

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

Interventions

Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback 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.

Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bulent Ecevit University: lead

MeSH Terms

Conditions

Dysmenorrhea; Menstruation Disturbances

Condition Hierarchy (Ancestors)

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

Study Officials

• Assistant Professor of Physiotherapy

  Zonguldak Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanem ŞENER

CONTACT

+90 553-591-83-96; sanemsener@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study uses a single-blind design in which the outcomes assessor is unaware of participants' group allocation. Participants and care providers are aware of the assigned interventions, but the assessor responsible for data collection and outcome evaluation remains blinded throughout the trial to reduce measurement bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: Participants will be randomly assigned into two parallel groups: an intervention group receiving abdominal muscle strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, and a control group receiving no such intervention during the study period. Both groups will be evaluated at baseline, mid-intervention, and post-intervention over an 8-week period.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: August 13, 2025
• Primary Completion: September 23, 2025
• Study Completion: September 25, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share