Primary Dysmenorrhea (PD)DPTDYSNCT07760376

Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students

A study testing Structured Physiotherapy Program and Conventional Treatment for Primary Dysmenorrhea in people with Primary Dysmenorrhea (PD), run by Muhammad Nawaz Sharif University of Agriculture Multan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Trial Summary Primary dysmenorrhea is a common condition among young women that can significantly impair daily functioning and health-related quality of life. This single-center randomized controlled trial evaluated the effectiveness of a 12-week structured physiotherapy program in 360 female Doctor of Physical… Read more about this study

Who is it for?: Ages 18 to 30 years, women only
Conditions the study is for: Primary Dysmenorrhea (PD)
What is being tested?: Structured Physiotherapy Program and Conventional Treatment for Primary Dysmenorrhea
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 sitePakistan
Study dates: 2 Feb 2026to 30 Jun 2026
Phase: Interventional
Are there results?: None posted in the registry

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 30 years
Women only
No healthy volunteers
Adult

Who may be able to join

Inclusion criteria were: regularly menstruating female DPT students aged 18-30 years; self-reported and clinically confirmed primary dysmenorrhea (pain commencing within 1-2 days of menstrual onset with no identifiable pelvic pathology); history of primary dysmenorrhea for at least the past four cycles with pain intensity ≥4 on the Visual Analogue Scale (VAS). Females who had sedentary lifestyle (engaging in <25 minutes of physical activity thrice weekly) and showed willingness to provide informed consent to participate in the study.

Who cannot join

Students with irregular menstrual cycles or secondary dysmenorrhea or diagnosed conditions such as endometriosis, amenorrhea, or other gynecological disorders; use of medications that could influence menstrual pain or cycle regularity, neuromuscular or chronic degenerative diseases; physical limitations impeding exercise participation; pregnancy or postpartum status during the study period. Not wanted to take part in the research.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Muhammad Institute of Medical and Allied Sciences Multan
Multan Khurd, 66000

Other trials in Pakistan

About this study

Official title: Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students: A Randomized Controlled Trial

Trial Summary

Primary dysmenorrhea is a common condition among young women that can significantly impair daily functioning and health-related quality of life. This single-center randomized controlled trial evaluated the effectiveness of a 12-week structured physiotherapy program in 360 female Doctor of Physical Therapy (DPT) students with primary dysmenorrhea. Participants were randomly allocated to either a structured physiotherapy intervention (n=180) or a control group receiving conventional treatment (n=180). The intervention consisted of supervised sessions three times per week, including general stretching, pelvic stretching, aerobic jogging, Kegel exercises, and progressive muscle relaxation. The primary outcome was the change in dysmenorrhea symptoms over three consecutive menstrual cycles, while secondary outcomes included health-related quality of life assessed using the SF-36 questionnaire. Compared with the control group, participants receiving structured physiotherapy demonstrated significant reductions in all assessed dysmenorrhea symptoms and significant improvements in physical functioning, bodily pain, general health perception, and vitality. Greater dysmenorrhea severity was associated with poorer quality-of-life scores, and structured physiotherapy independently predicted clinical improvement. The findings indicate that a structured multimodal physiotherapy program is an effective non-pharmacological intervention for reducing the severity of primary dysmenorrhea and improving selected domains of health-related quality of life in female DPT students.

Conditions: Primary Dysmenorrhea (PD)
Being tested: Structured Physiotherapy Program, Conventional Treatment for Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea, Structured Physiotherapy Exercise Therapy, Kegel Exercises, Aerobic Exercise, Stretching Exercises

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Structured Physiotherapy ProgramBehavioural
Participants received a supervised structured physiotherapy program three times per week for 12 weeks in addition to conventional treatment. Each 50-minute session consisted of five components: general stretching, specific pelvic stretching (Billig protocol), moderate-intensity aerobic jogging (60-70% of age-predicted maximum heart rate), Kegel exercises, and progressive muscle relaxation. The intervention was designed to reduce the severity of primary dysmenorrhea and improve health-related quality of life.
Conventional Treatment for Primary DysmenorrheaOther
Participants received conventional medical treatment for primary dysmenorrhea according to routine clinical practice throughout the 12-week study period. Conventional management included the use of standard analgesic or nonsteroidal anti-inflammatory medications as prescribed by the treating physician. Participants continued their usual daily activities and did not receive the structured physiotherapy intervention.

Study groups in NCT07760376
Study group	Role	What they receive
Structured Physiotherapy Program	Experimental	Participants received a structured physiotherapy program in addition to conventional treatment for 12 weeks. The intervention consisted of supervised sessions three times per week, with each 50-minute session including general stretching, specific pelvic stretching (Billig protocol), moderate-intensity aerobic jogging, Kegel exercises, and progressive muscle relaxation. The program was designed to reduce dysmenorrhea symptoms and improve health-related quality of life. Receives: Behavioral: Structured Physiotherapy Program
Conventional Treatment	Active comparator	Participants received conventional treatment for primary dysmenorrhea according to routine clinical practice for 12 weeks. They continued their usual daily activities and did not participate in the structured physiotherapy program. This arm served as the active comparator to evaluate the effectiveness of the structured physiotherapy intervention. Receives: Other: Conventional Treatment for Primary Dysmenorrhea

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity (VAS)
The main outcome measure was pain intensity during menstruation, which was evaluated via Visual Analogue Scale (VAS). The Visual Analogue Scale consists of a horizontal line 10 cm long with the labels of "no pain at all" and "unbearable pain" on both sides. Participants were asked to draw a line on the scale showing how much pain they felt and this number was measured in centimeters from "no pain" side of the scale. Numbers between 1-3 cm reflected mild dysmenorrhea, numbers between 4-7 cm reflected moderate dysmenorrhea, while numbers from 8-10 cm reflected severe dysmenorrhea
Measured: 12 weeks

Secondary outcomes (2)

Dysmenorrhea Severity (MSS)
Multidimensional Scoring System (MSS) was employed as a secondary outcome measure to classify the dysmenorrhea in a multidimensional manner according to the level of abdominal pain, activity restriction, and requirement for painkiller drugs. Dysmenorrhea is classified by MSS into three levels depending upon the severity of abdominal pain, activity restriction, and need of taking analgesic drugs, namely mild, moderate, and severe. MSS score was determined at the baseline and end of each menstrual cycle throughout the trial period, as it was for the VAS scoring procedure.
Measured: 12 weeks
Health-Related Quality of Life (SF-36)
The secondary outcome measure for the assessment of HRQoL involved the Medical Outcomes Study Short Form-36 (SF-36) Health Survey Questionnaire. SF-36 is the most commonly used and validated generic instrument for assessing HRQoL, with high reliability and responsiveness that have been shown through numerous studies. The instrument includes 36 questions, divided into eight scales: physical functioning, role limitations because of physical difficulties (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations because of emotional problems (role-emotional), and mental health. Scores for each scale range from 0 to 100; the higher scores are, the better HRQoL patients have. Patients underwent SF-36 at baseline (week 0) and week 12 (endpoint) of the study in order to evaluate the impact of the structured physiotherapy intervention on their HRQoL.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 202630 Jun 2026

First posted12 Aug 2026
Study start2 Feb 2026
Primary completion30 Jun 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the intervention group received a structured physiotherapy program in addition to conventional treatment, while the control group received conventional treatment alone. Both groups were followed concurrently for 12 weeks, and outcomes were assessed at baseline and after completion of the intervention.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07760376
Sponsor's protocol ID: MNSUAM/05/28/IAK
Acronym: DPTDYS
Status last verified: Aug 2026
First submitted: 7 Aug 2026
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean J Fam Med. 2022;43(2):101-108. 2. Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21(6):762-778. 3. Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021;21:392. 4. Dar M, Khan A, Shah SS, Aleem A, Jaber AAS, Hussain M, Khan GM. Evaluation of health-related quality of life of female students suffering from primary dysmenorrhea: findings of a cross-sectional study from Pakistan. Front Public Health. 2025;13:1467377. 5. Kamel DM, Tantawy SA, Abdelsamea GA. Experience of dysmenorrhea among a group of physical therapy students from Cairo University: an exploratory study. J Pain Res. 2017;10:1079-1085. 6. Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014;60(1):13-21. 7. Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018;219(3):255.e1-255.e20. 8. Tsai IC, Hsu CW, Chang CH, Lei WT, Tseng PT, Chang KV. Comparative effectiveness of different exercises for reducing pain intensity in primary dysmenorrhea: a systematic review and network meta-analysis of randomized controlled trials. Sports Med Open. 2024;10:62. 9. Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006;332(7550):1134-1138. 10. Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015;2015(7):CD001751. 11. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 12. Faul F, Erdfeld

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07760376
Acronym / sponsor ID: DPTDYS / MNSUAM/05/28/IAK
Conditions: Primary Dysmenorrhea (PD)
Keywords: Primary Dysmenorrhea, Structured Physiotherapy Exercise Therapy, Kegel Exercises, Aerobic Exercise, Stretching Exercises
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Muhammad Nawaz Sharif University of Agriculture MultanUniversity, hospital or other
Study start: 2 Feb 2026 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 12 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.

Trial Summary

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the intervention group received a structured physiotherapy program in addition to conventional treatment, while the control group received conventional treatment alone. Both groups were followed concurrently for 12 weeks, and outcomes were assessed at baseline and after completion of the intervention.

Arm	Type	Receives
Structured Physiotherapy Program	Experimental	Behavioral: Structured Physiotherapy ProgramParticipants received a structured physiotherapy program in addition to conventional treatment for 12 weeks. The intervention consisted of supervised sessions three times per week, with each 50-minute session including general stretching, specific pelvic stretching (Billig protocol), moderate-intensity aerobic jogging, Kegel exercises, and progressive muscle relaxation. The program was designed to reduce dysmenorrhea symptoms and improve health-related quality of life.
Conventional Treatment	Active comparator	Other: Conventional Treatment for Primary DysmenorrheaParticipants received conventional treatment for primary dysmenorrhea according to routine clinical practice for 12 weeks. They continued their usual daily activities and did not participate in the structured physiotherapy program. This arm served as the active comparator to evaluate the effectiveness of the structured physiotherapy intervention.

Who may qualify

Ages: 18 to 30 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Inclusion criteria were: regularly menstruating female DPT students aged 18-30 years; self-reported and clinically confirmed primary dysmenorrhea (pain commencing within 1-2 days of menstrual onset with no identifiable pelvic pathology); history of primary dysmenorrhea for at least the past four cycles with pain intensity ≥4 on the Visual Analogue Scale (VAS). Females who had sedentary lifestyle (engaging in <25 minutes of physical activity thrice weekly) and showed willingness to provide informed consent to participate in the study.

Key exclusion criteria (1 listed)

Students with irregular menstrual cycles or secondary dysmenorrhea or diagnosed conditions such as endometriosis, amenorrhea, or other gynecological disorders; use of medications that could influence menstrual pain or cycle regularity, neuromuscular or chronic degenerative diseases; physical limitations impeding exercise participation; pregnancy or postpartum status during the study period. Not wanted to take part in the research.

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
Structured Physiotherapy ProgramParticipants received a supervised structured physiotherapy program three times per week for 12 weeks in addition to conventional treatment. Each 50-minute session consisted of five components: general stretching, specific pelvic stretching (Billig protocol), moderate-intensity aerobic jogging (60-70% of age-predicted maximum heart rate), Kegel exercises, and progressive muscle relaxation. The intervention was designed to reduce the severity of primary dysmenorrhea and improve health-related quality of life.	Behavioural	Structured Physiotherapy Program
Conventional Treatment for Primary DysmenorrheaParticipants received conventional medical treatment for primary dysmenorrhea according to routine clinical practice throughout the 12-week study period. Conventional management included the use of standard analgesic or nonsteroidal anti-inflammatory medications as prescribed by the treating physician. Participants continued their usual daily activities and did not receive the structured physiotherapy intervention.	Other	Conventional Treatment

Primary outcome

Pain Intensity (VAS)
Time frame: 12 weeks
The main outcome measure was pain intensity during menstruation, which was evaluated via Visual Analogue Scale (VAS). The Visual Analogue Scale consists of a horizontal line 10 cm long with the labels of "no pain at all" and "unbearable pain" on both sides. Participants were asked to draw a line on the scale showing how much pain they felt and this number was measured in centimeters from "no pain" side of the scale. Numbers between 1-3 cm reflected mild dysmenorrhea, numbers between 4-7 cm reflected moderate dysmenorrhea, while numbers from 8-10 cm reflected severe dysmenorrhea

2 secondary outcomes

Dysmenorrhea Severity (MSS)
Time frame: 12 weeks
Health-Related Quality of Life (SF-36)
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
BackgroundItani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary dysmenorrhea: pathophysiology, diagnosis, and treatment updates. Korean J Fam Med. 2022;43(2):101-108. 2. Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21(6):762-778. 3. Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021;21:392. 4. Dar M, Khan A, Shah SS, Aleem A, Jaber AAS, Hussain M, Khan GM. Evaluation of health-related quality of life of female students suffering from primary dysmenorrhea: findings of a cross-sectional study from Pakistan. Front Public Health. 2025;13:1467377. 5. Kamel DM, Tantawy SA, Abdelsamea GA. Experience of dysmenorrhea among a group of physical therapy students from Cairo University: an exploratory study. J Pain Res. 2017;10:1079-1085. 6. Kannan P, Claydon LS. Some physiotherapy treatments may relieve menstrual pain in women with primary dysmenorrhea: a systematic review. J Physiother. 2014;60(1):13-21. 7. Matthewman G, Lee A, Kaur JG, Daley AJ. Physical activity for primary dysmenorrhea: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2018;219(3):255.e1-255.e20. 8. Tsai IC, Hsu CW, Chang CH, Lei WT, Tseng PT, Chang KV. Comparative effectiveness of different exercises for reducing pain intensity in primary dysmenorrhea: a systematic review and network meta-analysis of randomized controlled trials. Sports Med Open. 2024;10:62. 9. Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006;332(7550):1134-1138. 10. Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015;2015(7):CD001751. 11. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988. 12. Faul F, Erdfeld
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. This study is not recruiting at the moment.

Imran A Khan, PhD principal investigator

Muhammad Nawaz Sharif University of Agriculture Multan

Maliha K Khan, DPT, MSPH study director

Muhammad Institute of Medical and Allied Sciences Multan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07760376, which also lists 1 linked publication.

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 13 Aug 2026.