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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Physical Activity Level
研究概览
简要总结
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.
详细描述
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.
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 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).
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
- •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 ≥
- •Able and willing to participate in thrice-weekly physiotherapy sessions for eight weeks.
- •Provide written informed consent.
排除标准
- •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.
结局指标
主要结局
Physical Activity Level
时间窗: 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
时间窗: 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.
Severity of Pain
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Compliance Rate(End of 8th week)