Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students (DPTDYS)
2026年8月11日 更新者：Imran Ahmad Khan、Muhammad Nawaz Sharif University of Agriculture Multan
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.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (実際)
入学
360
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Multan Khurd、パキスタン、66000
- Muhammad Institute of Medical and Allied Sciences Multan
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Intensity (VAS)
時間枠：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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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dysmenorrhea Severity (MSS)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- 主任研究者：Imran A Khan, PhD、Muhammad Nawaz Sharif University of Agriculture Multan
- スタディディレクター：Maliha K Khan, DPT, MSPH、Muhammad Institute of Medical and Allied Sciences Multan
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年2月2日
一次修了 (実際)
一次修了
2026年6月30日
研究の完了 (実際)
研究の完了
2026年6月30日
試験登録日
最初に提出
最初に提出
2026年8月7日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年8月7日
最初の投稿 (実際)
最初の投稿
2026年8月12日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月13日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- MNSUAM/05/28/IAK
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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