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RECRUITING Not applicable ClinicalTrials.gov

Diaphragm-Pelvic Floor Synergy Training in Young Females With Primary Dysmenorrhea.

Sponsor: Riphah International University • ClinicalTrials.gov ID: NCT07754305

Registry updated: 2026-08-26
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Description

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.

Interventions

  • Diaphragm-Pelvic Floor Synergy (DPFS) Training (Behavioral)
    This intervention is a supervised 8-week program consisting of 3 sessions per week. It focuses on the functional coordination of the thoracic diaphragm and pelvic floor muscles to regulate intra-abdominal pressure. The protocol involves a "piston" technique where participants perform a 4-second slow inhalation (allowing the pelvic floor to relax and descend) followed by a 6-second pursed-lip exhalation (actively contracting and elevating the pelvic floor). The training is progressive, advancing every two weeks through four postural levels: supine, sitting, quadruped, and standing.
  • Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
    This arm receives established clinical treatments for menstrual pain. During the first three days of the menstrual cycle, participants receive 30 minutes of High-Frequency Transcutaneous Electrical Nerve Stimulation (TENS) at 100 Hz and 20 minutes of moist heat therapy. On non-menstrual days, they participate in supervised Progressive Muscle Relaxation (PMR) sessions three times per week to manage general muscle tension and stress.

Eligibility criteria

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

Conditions

Dysmenorrhea

Locations

  • Prime Institute of Health Sciences, Islamabad — Islamabad, Punjab Province, Pakistan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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