Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Pain Intensity (VAS)
研究概览
简要总结
**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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Structured Physiotherapy Program (Behavioral)
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.
干预措施: Conventional Treatment for Primary Dysmenorrhea (Other)
结局指标
主要结局
Pain Intensity (VAS)
时间窗: 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
次要结局
- Health-Related Quality of Life (SF-36)(12 weeks)
- Dysmenorrhea Severity (MSS)(12 weeks)
研究者
Imran Ahmad Khan
Principal Investigator
Muhammad Nawaz Sharif University of Agriculture Multan