Effects of Diaphragm-Pelvic Floor Synergy Training on Pain and Quality of Life in Young Females With Primary Dysmenorrhea.
| Registry | NCT07754305 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 64 (Estimated) |
| Sponsor | Riphah International University (Other) |
| Conditions | Dysmenorrhea |
| Interventions | Diaphragm-Pelvic Floor Synergy (DPFS) Training, Transcutaneous Electrical Nerve Stimulation (TENS) (Behavioral, device) |
| Dates | start 2026-08-12, primary completion 2026-11-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-08-10, last updated 2026-08-26 |
| Locations | 1 site in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Dysmenorrhea All trials of Diaphragm-Pelvic Floor Synergy (DPFS) Training All trials of Transcutaneous Electrical Nerve Stimulation (TENS)
The research investigating the effects of Diaphragm-Pelvic Floor Synergy (DPFS) training targets primary dysmenorrhea in university-aged females. This randomized controlled trial evaluates how restoring the functional "piston" relationship between the diaphragm and pelvic floor can alleviate menstrual pain and enhance quality of life. By implementing an eight-week progressive exercise protocol, the study compares DPFS training against standard symptomatic care like TENS and heat therapy. Using the WALIDD scale and WHOQOL-BREF, the research aims to establish a non-pharmacological, evidence-based physiotherapy intervention that reduces medication reliance and academic absenteeism in South Asian clinical settings.
The research investigates the functional relationship between the thoracic diaphragm and pelvic floor muscles, often described as a "piston" mechanism, and its role in managing primary dysmenorrhea. In healthy individuals, these muscle groups contract and relax in coordination to regulate intra-abdominal pressure and provide core stability. However, young females with primary dysmenorrhea frequently experience disrupted synergy due to shallow breathing and increased pelvic tension, which exacerbates the intensity of menstrual cramps and negatively impacts their physical and psychological well-being. To address this, a randomized controlled trial will be conducted at the Prime Institute of Health Sciences, involving 64 participants aged 18 to 25. The study compares a structured eight-week Diaphragm-Pelvic Floor Synergy (DPFS) training program against standard symptomatic care, such as TENS and heat therapy. The intervention group will perform specific exercises three times per week, progressing from supine to standing positions to challenge the core muscles under varying gravitational loads. This progression aims to recalibrate the respiratory-pelvic coordination and improve neuromuscular control.
Outcomes are measured using the WALIDD scale for pain severity and the WHOQOL-BREF for quality of life assessments. By focusing on the physiological root of core instability rather than just temporary symptom suppression, the study aims to establish an evidence-based physiotherapy protocol. This approach offers a sustainable, non-pharmacological alternative for managing menstrual pain, ultimately seeking to reduce academic absenteeism and long-term reliance on analgesics among young women in South Asian clinical settings.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diaphragm-Pelvic Floor Synergy (DPFS) Training | Experimental | Behavioral: Diaphragm-Pelvic Floor Synergy (DPFS) Training | Participants in this group undergo an active neuromuscular re-education protocol. The intervention focuses on restoring the "piston-like" coordination between the thoracic diaphragm and the pelvic floor muscles. Over an 8-week period, participants perform supervised exercises three times per week that synchronize breathing with pelvic floor activation. The training is progressive, advancing through four postural stages (supine, sitting, quadruped, and standing) to challenge the core's ability to regulate intra-abdominal pressure and alleviate symptoms of primary dysmenorrhea. |
| Standard Symptomatic Care | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS) | This group serves as the clinical control, receiving conventional physiotherapy typically used for menstrual pain relief. During the first three days of the menstrual cycle, participants receive passive modalities, including High-Frequency Transcutaneous Electrical Nerve Stimulation (TENS) and moist heat therapy. On non-menstrual days, the group performs supervised Progressive Muscle Relaxation (PMR) three times per week. This design ensures that the control group remains as active as the experimental group while receiving standard-of-care treatments for symptom management. |
Sex: Female, ages: 18 Years to 24 Years
Inclusion Criteria: 1. University going girls aged 18-24 years. 2. Normal weight (BMI 18.5-24.9 kg/m²) based on measured height and weight. 3. Primary dysmenorrhea: recurrent menstrual pain without pelvic pathology, present for ≥6 months, with pain intensity ≥4/10 on VAS. 4. Regular menstrual cycles (21-35 days). 5. From socioeconomically disadvantaged backgrounds (e.g., low parental education, low household income, government/public school enrolment - specify in protocol). 6. Currently enrolled in school/college. 7. Informed consent/assent obtained (with parental consent if <18 years). 8. Willing to participate in intervention and data collection. Exclusion Criteria: 1. diagnosed pelvic pathologies (e.g., endometriosis, fibroids, pelvic inflammatory disease). 2. Irregular menstrual cycles (<21 days or >35 days). 3. Current or recent use of hormonal contraceptives or hormonal therapy (within last 3 months). 4. History of pelvic/abdominal surgery. 5. Pregnancy or recent childbirth (within 6 months). 6. Any diagnosed musculoskeletal, neurological, or medical condition contraindicating exercise or acupressure. 7. Current participation in another clinical trial or structured exercise/physiotherapy program for dysmenorrhea. 8. Unwillingness to provide consent/assent or comply with study procedures
| Facility | City | Country | Status |
|---|---|---|---|
| Prime Institute of Health Sciences, Islamabad | Islamabad, Punjab Province | Pakistan | Recruiting |