Comparative Effects of Sacral Release Technique and Lumbar Mobilization in Pain, Symptoms Severity and Quality of Life in Primary Dysmenorrhea.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
The aim of this study is to determine the comparative effects of sacral release technique and lumbar mobilization in pain, symptoms severity and quality of life in primary dysmenorrhea.
详细描述
This will be a randomized clinical trial, the study will be conducted at First Care Medical Complex, over 10 month duration, involving a 46 adolescent females aged 13-19 years diagnosed with primary dysmenorrhea selected through a non-probability convenience sampling technique. Participants will be randomly assigned to two intervention groups. Group A (n=23) will receive the Sacral Release Technique and Group B (n=23) will undergo Lumbar Mobilization. Interventions will provide for 6 weeks, 3 sessions per cycle for two consecutive menstrual cycles. Pain intensity will be measured by using the Numerical Pain Rating Scale (NPRS) and menstrual symptom severity will be evaluated using a structured symptom rating tool, and quality of life will be measured using EuroQOL. Data will be analyzed using SPSS version 25, and with p-value of <0.05 will be considered statistically significant.
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)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Unmarried female
- •Diagnosed with primary dysmenorrhea through WaLIDD Score
- •Regular menstrual cycles (21-35 days)
- •Pain score of > 4 on the Numerical Pain Rating Scale (NPRS) during menstruation
排除标准
- •Any pelvic inflammatory disease
- •Spinal deformity
- •Lumber radiculopathy
- •Heavy menstrual bleeding (menorrhagia)
- •Irregular menstrual cycles
- •Spine trauma and coccyx pain
- •History of pelvic or spinal surgery currently on hormonal therapy or other ongoing physiotherapy for dysmenorrhea
研究组 & 干预措施
LUMBAR MOBILIZATION
Lumbar mobilization is a manual therapy technique used to relieve pain, restore joint motion, and improve mobility in the lower spine.
干预措施: LUMBAR MOBILIZATION (Other)
SACRAL RELEASE TECHNIQUE
The sacral release technique is a gentle, non-invasive method used to relieve tension in the sacral area, improve pelvic alignment, and enhance overall comfort, particularly during pregnancy
干预措施: SACRAL RELEASE TECHNIQUE (Other)
结局指标
主要结局
Numerical Pain Rating Scale (NPRS)
时间窗: 6th week
The Numerical Pain Rating Scale (NPRS) is a unidimensional scale ranging from 0 (no pain) to 10 (worst possible pain). The NPRS demonstrates excellent test-retest reliability, with Intraclass Correlation Coefficients (ICC) typically above 0.90, indicating stability of responses over time. Its internal consistency has been shown to be high, with Cronbach's alpha values ranging from 0.86 to 0.95, reflecting a strong degree of reliability. The tool also has validity as it correlates significantly with other pain-related outcome measures domains of quality-of-life instruments
Menstrual Symptom Questionnaire (MSQ)
时间窗: 6th week
It is a validated instrument designed to assess the frequency and intensity of common menstrual-related symptoms, including pain, mood changes, fatigue, bloating, and general discomfort. It provides a comprehensive overview of both physical and emotional aspects of menstruation, making it suitable for evaluating the effectiveness of interventions in conditions like primary dysmenorrhea. The scale demonstrates acceptable internal consistency, with a reported Cronbach's alpha of 0.78, indicating reliable measurement across diverse symptom domain
EuroQol-5 Dimension Questionnaire (EQ-5D)
时间窗: 6th week
The EuroQol-5 Dimension Questionnaire (EQ-5D) is assessing health-related quality of life in women with primary dysmenorrhea. The internal consistency of the EQ-5D in related populations have reported a Cronbach's alpha ranging from 0.70 to 0.89, indicating acceptable to excellent reliability
次要结局
未报告次要终点