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

NCT07754305 | Not Yet Recruiting DMC

• 1 other identifier: Rida Zia Chaudhary
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysmenorrhea

Keywords

Diaphragm-Pelvic Floor Synergy; Quality of Life; Young Females; Primary Dysmenorrhea

Outcome Measures

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.

  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)

  Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).

Study Arms (2)

Diaphragm-Pelvic Floor Synergy (DPFS) Training

EXPERIMENTAL

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

Standard Symptomatic Care

ACTIVE COMPARATOR

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)

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.

Diaphragm-Pelvic Floor Synergy (DPFS) Training

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.

Standard Symptomatic Care

Eligibility Criteria

• Age: 18 Years - 24 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Prime Institute of Health Sciences, Islamabad

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Summra Andleeb, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summra Andleeb, MSOMPT

CONTACT

03450510617872; summer.spring90@gmail.com

Rida Zafar, WHPT

CONTACT

03368753273; rida.zafar@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: July 28, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)