Diaphragm-Pelvic Floor Synergy Training in Young Females With Primary Dysmenorrhea.
ConditionDysmenorrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-24
SponsorRiphah International University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
University going girls aged 18-24 years.
Normal weight (BMI 18.5-24.9 kg/m²) based on measured height and weight.
Primary dysmenorrhea: recurrent menstrual pain without pelvic pathology, present for ≥6 months, with pain intensity ≥4/10 on VAS.
Regular menstrual cycles (21-35 days).
Disqualifiers
diagnosed pelvic pathologies (e.g., endometriosis, fibroids, pelvic inflammatory disease).
Irregular menstrual cycles (<21 days or >35 days).
Current or recent use of hormonal contraceptives or hormonal therapy (within last 3 months).
History of pelvic/abdominal surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Diaphragm-Pelvic Floor Synergy (DPFS) Training
BehavioralThis 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)
DeviceThis 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Diaphragm-Pelvic Floor Synergy (DPFS) TrainingExperimental treatment 1 intervention
Group B: Standard Symptomatic CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Working Ability, Location, Intensity, Days of pain, and Dysmenorrhea (WALIDD) Scale
The WALIDD scale is a validated multi-dimensional tool used to assess the severity of primary dysmenorrhea. It evaluates five specific areas: work interference, anatomical location of pain, pain intensity, duration of symptoms, and the clinical grade of dysmenorrhea. Scores range from 0 to 12, where 1-4 indicates mild, 5-7 moderate, and 8-12 severe pain.
Time frame
Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).Secondary outcomes
1
: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
This is a 26-item questionnaire used to assess quality of life across four major domains: physical health, psychological health, social relationships, and environment. It measures how the intervention impacts the participants' overall well-being and daily functioning. Each item is rated on a 5-point Likert scale.
Time frame
Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).Sponsors and contacts
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Source ClinicalTrials.gov