Trials / Completed
CompletedNCT07052487
Effectiveness of Post Isometric Relaxation Technique Versus Simple Stretching Exercises for Pain and Physical Activity in Young Females With Primary Dysmenorrhea in Peshawar
Effectiveness of Post Isometric Relaxation Technique Versus Simple Stretching Exercises for Pain and Physical Activity in Young Females With Primary Dysmenorrhea in Peshawar: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Khyber Medical University Peshawar · Academic / Other
- Sex
- Female
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Post-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). |
| PROCEDURE | Simple 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). |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2025-09-10
- Completion
- 2025-10-30
- First posted
- 2025-07-04
- Last updated
- 2026-01-05
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT07052487. Inclusion in this directory is not an endorsement.