An interventional study of Diaphragm-Pelvic Floor Synergy (DPFS) Training and Transcutaneous Electrical Nerve Stimulation (TENS) in Dysmenorrhea, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Riphah International University · Not applicable, Interventional, and Other
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 64 is close to the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Diaphragm-Pelvic Floor Synergy (DPFS) Training
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.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
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.
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.
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).
: 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).
Plan to share: No
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