NCT07760376

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 7, 2026

Last Update Submit

August 11, 2026

Conditions

Keywords

Primary DysmenorrheaStructured Physiotherapy Exercise TherapyKegel ExercisesAerobic ExerciseStretching Exercises

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (2)

  • Dysmenorrhea Severity (MSS)

    12 weeks

  • Health-Related Quality of Life (SF-36)

    12 weeks

Study Arms (2)

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.

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.

Other: Conventional Treatment for Primary Dysmenorrhea

Interventions

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.

Structured Physiotherapy Program

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.

Conventional Treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was restricted to self-identified female participants because primary dysmenorrhea occurs in menstruating females. Only female Doctor of Physical Therapy students meeting the eligibility criteria were enrolled.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Institute of Medical and Allied Sciences Multan

Multan Khurd, 66000, Pakistan

Location

Related Publications (1)

  • 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

    BACKGROUND

Study Officials

  • Imran A Khan, PhD

    Muhammad Nawaz Sharif University of Agriculture Multan

    PRINCIPAL INVESTIGATOR
  • Maliha K Khan, DPT, MSPH

    Muhammad Institute of Medical and Allied Sciences Multan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to participants' group allocation throughout the study. They were responsible for collecting and recording outcome measures, including dysmenorrhea symptom scores and SF-36 quality-of-life assessments, without knowledge of whether participants had been assigned to the structured physiotherapy intervention or the control group, thereby minimizing assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start

February 2, 2026

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations