Primary Dysmenorrhea (PD)
Conditions
Keywords
Primary Dysmenorrhea, Structured Physiotherapy Exercise Therapy, Kegel Exercises, Aerobic Exercise, Stretching Exercises
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.
Interventions
BEHAVIORALStructured Physiotherapy Program
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.
OTHERConventional Treatment for Primary Dysmenorrhea
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.
Sponsors
Muhammad Nawaz Sharif University of Agriculture Multan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (VAS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dysmenorrhea Severity (MSS) | 12 weeks | 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. |
| Health-Related Quality of Life (SF-36) | 12 weeks | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORImran A Khan, PhD
Muhammad Nawaz Sharif University of Agriculture Multan
STUDY_DIRECTORMaliha K Khan, DPT, MSPH
Muhammad Institute of Medical and Allied Sciences Multan
Outcome results
None listed