- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07760376
Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students (DPTDYS)
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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Multan Khurd, Pákistán, 66000
- Muhammad Institute of Medical and Allied Sciences Multan
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Structured Physiotherapy Program
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.
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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.
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Aktivní komparátor: Conventional Treatment
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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Pain Intensity (VAS)
Časové okno: 12 weeks
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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
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12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dysmenorrhea Severity (MSS)
Časové okno: 12 weeks
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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.
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12 weeks
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Health-Related Quality of Life (SF-36)
Časové okno: 12 weeks
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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.
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12 weeks
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Imran A Khan, PhD, Muhammad Nawaz Sharif University of Agriculture Multan
- Ředitel studie: Maliha K Khan, DPT, MSPH, Muhammad Institute of Medical and Allied Sciences Multan
Publikace a užitečné odkazy
Obecné publikace
- 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
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
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