DysmenorrheaNCT07754305
Diaphragm-Pelvic Floor Synergy Training in Young Females With Primary Dysmenorrhea.
A study testing Diaphragm-Pelvic Floor Synergy (DPFS) Training and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Diaphragm-Pelvic Floor Synergy (DPFS) Training and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Aug 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Prime Institute of Health Sciences, Islamabad
Islamabad, Punjab Province, 44000
About this study
Official title: Effects of Diaphragm-Pelvic Floor Synergy Training on Pain and Quality of Life in Young Females With Primary Dysmenorrhea.
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.
Read the 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.
- Conditions
- Dysmenorrhea
- Being tested
- Diaphragm-Pelvic Floor Synergy (DPFS) Training, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Diaphragm-Pelvic Floor Synergy, Quality of Life, Young Females, Primary Dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm-Pelvic Floor Synergy (DPFS) TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start12 Aug 2026
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Summra Andleeb, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754305
- Sponsor's protocol ID
- Rida Zia Chaudhary
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm-Pelvic Floor Synergy Training on Pain and Quality of Life in Young Females With Primary Dysmenorrhea.
- ClinicalTrials.gov ID
- NCT07754305
- Acronym / sponsor ID
- Rida Zia Chaudhary
- Conditions
- Dysmenorrhea
- Keywords
- Diaphragm-Pelvic Floor Synergy, Quality of Life, Young Females, Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm-Pelvic Floor Synergy (DPFS) Training | Experimental | Behavioral: Diaphragm-Pelvic Floor Synergy (DPFS) TrainingParticipants 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. |
| Standard Symptomatic Care | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm-Pelvic Floor Synergy (DPFS) TrainingThis 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. | Behavioural | Diaphragm-Pelvic Floor Synergy (DPFS) Training |
| Transcutaneous Electrical Nerve Stimulation (TENS)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. | Device | Standard Symptomatic Care |
Primary outcome
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.
1 secondary outcome
: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Baseline (Pre-intervention), 8 weeks (Immediate post-intervention), and 3 months (Follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Summra Andleeb, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm-Pelvic Floor Synergy (DPFS) Training and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Dysmenorrhea, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summra Andleeb, MSOMPT (03450510617872, summer.spring90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.