Dysmenorrhea, Menstrual Pain
Conditions
Keywords
Dysmenorrhea, Menstrual Pain, Pelvic Pain, Exercise Therapy, Physical Therapy Modalities
Brief summary
This randomized controlled trial will compare the effectiveness of Post-Isometric Relaxation (PIR) versus Simple Stretching Exercises (SSE), each combined with standard physiotherapy modalities, for reducing menstrual pain and improving physical activity in young unmarried women with primary dysmenorrhea. Forty-four participants will be randomly assigned (1:1) to receive either PIR or SSE three times per week for eight weeks (24 total sessions). The study will identify which non-pharmacological intervention provides superior benefits for pain relief and daily function.
Detailed description
Primary dysmenorrhea is defined as menstrual cramps without underlying disease. This condition affects 50-90% of women of reproductive age and can significantly impair daily activities and quality of life. While pharmacologic treatments exist, non-drug interventions which include muscle energy techniques and stretching are under investigation for their safety and efficacy. In this single-center, parallel-group randomized controlled trial, 44 unmarried female students aged 18-30 years with documented regular menstrual cycles and moderate to severe primary dysmenorrhea (WaLIDD score ≥5) will be enrolled. After baseline screening and informed consent, participants will be randomized (via OpenEpi) to one of two groups of post-isometric relaxation technique and simple stretching exercises. Pain intensity (NPRS 0-10) and physical activity levels (IPAQ MET·min/week) will be assessed at baseline, 4 weeks, and 8 weeks by blinded assessors. Secondary measures include dysmenorrhea severity (WaLIDD questionnaire) and range of motion. Data will be analyzed with RM-ANOVA for within-group changes and independent-samples t-tests for between-group comparisons, after testing normality with Shapiro-Wilk. A p-value \<0.05 denotes significance. This trial will clarify which non-pharmacological intervention more effectively reduces menstrual pain and enhances activity, informing evidence-based physiotherapy protocols for primary dysmenorrhea.
Interventions
PROCEDUREPost-Isometric Relaxation (PIR)
A manual physiotherapy technique applied to the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of transcutaneous electrical nerve stimulation (TENS) and moist heat (hot-pack), followed by three cycles per muscle group of: a 10-second isometric contraction against the therapist's counterforce, 5-second relaxation, and 30-second passive stretch. Sessions are delivered thrice weekly for eight weeks (24 sessions total).
PROCEDURESimple Stretching Exercises (SSE)
A set of four static stretches targeting the gluteus maximus, iliopsoas, piriformis, and hamstrings. Each session begins with 10 minutes of TENS and hot-pack application, followed by ten repetitions of each stretch held for 10 seconds. Sessions are delivered thrice weekly for eight weeks (24 sessions total).
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to each participant's group assignment. Participants, care providers, and investigators will be aware of group allocation (open-label for all other roles).
Intervention model description
This study is a two-arm, parallel-group, randomized clinical trial with 44 participants assigned in a 1:1 ratio to either the Post-Isometric Relaxation (PIR) group or the Simple Stretching Exercises (SSE) group. Allocation will be performed centrally using a computer-generated random sequence and sealed envelopes to ensure concealment. The trial is open-label for participants, care providers, and investigators; however, outcome assessors will remain blinded to group assignments to minimize assessment bias. Primary outcomes (pain intensity via NPRS and physical activity via IPAQ) and secondary outcomes (WaLIDD score and range of motion) will be collected at baseline, week 4, and week 8 by these blinded assessors.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 18-30 years. * Self-identification as female. * Unmarried students with regular menstrual cycles (24-35 days). * Diagnosed primary dysmenorrhea with a WaLIDD score ≥ 5. * Able and willing to participate in thrice-weekly physiotherapy sessions for eight weeks. * Provide written informed consent.
Exclusion criteria
* Secondary dysmenorrhea (e.g., endometriosis, pelvic inflammatory disease). * Current use of hormonal contraceptives or any medication for menstrual pain. * History of hip or pelvic surgery in the past year. * Acute musculoskeletal injury or chronic pain conditions unrelated to dysmenorrhea. * Neurological disorders affecting lower-limb muscle function. * Contraindications to TENS or heat therapy (e.g., skin lesions, implanted electronic devices). * Pregnancy or breastfeeding. * Participation in another interventional trial within the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Pain | Baseline, Week 4, and Week 8 (8 weeks total) | Numeric Pain Rating Scale will be used to measure the pain intensity. Difference from baseline in average menstrual pain intensity, measured using the 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain). Participants rate their typical pain during the first two days of menstruation. |
| Physical Activity Level | Baseline, Week 4, and Week 8 (8 weeks total) | Difference from baseline in total weekly metabolic equivalent task minutes (MET-min/week), as assessed by the short-form International Physical Activity Questionnaire. |
| Dysmenorrhea Severity | Baseline, Week 4, and Week 8 | Change from baseline in the Work Ability, Location, Intensity, Days of pain and Dysmenorrhea (WaLIDD) questionnaire score. The WaLIDD score ranges from 0 to 12, with higher scores indicating more severe dysmenorrhea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance Rate | End of 8th week | Percentage of prescribed sessions attended out of 24 planned sessions. |
Countries
Pakistan
Outcome results
None listed