- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07754305
Diaphragm-Pelvic Floor Synergy Training in Young Females With Primary Dysmenorrhea.
Effects of Diaphragm-Pelvic Floor Synergy Training on Pain and Quality of Life in Young Females With Primary Dysmenorrhea.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Summra Andleeb, MSOMPT
- Phone Number: 03450510617872
- Email: summer.spring90@gmail.com
Study Contact Backup
- Name: Rida Zafar, WHPT
- Phone Number: 03368753273
- Email: rida.zafar@riphah.edu.pk
Study Locations
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Punjab Province
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Islamabad, Punjab Province, Pakistan, 44000
- Recruiting
- Prime Institute of Health Sciences, Islamabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
- From socioeconomically disadvantaged backgrounds (e.g., low parental education, low household income, government/public school enrolment - specify in protocol).
- Currently enrolled in school/college.
- Informed consent/assent obtained (with parental consent if <18 years).
- Willing to participate in intervention and data collection.
Exclusion Criteria:
- 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.
- Pregnancy or recent childbirth (within 6 months).
- Any diagnosed musculoskeletal, neurological, or medical condition contraindicating exercise or acupressure.
- Current participation in another clinical trial or structured exercise/physiotherapy program for dysmenorrhea.
- Unwillingness to provide consent/assent or comply with study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
|
|
Active Comparator: Standard Symptomatic Care
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working Ability, Location, Intensity, Days of pain, and Dysmenorrhea (WALIDD) Scale
Time Frame: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
|
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.
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Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
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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.
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Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Summra Andleeb, MSOMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathologic Processes
- Pelvic Pain
- Menstruation Disturbances
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Dysmenorrhea
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Analgesia
- Transcutaneous Electric Nerve Stimulation
Other Study ID Numbers
- Rida Zia Chaudhary
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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