Efficacy of Pelvic Nerve Mobilization in Reducing Symptoms of Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Menstrual pain intensity
研究概览
简要总结
Primary dysmenorrhea is a highly prevalent condition among young women and is associated with significant pain, reduced quality of life, and academic absenteeism. Although non-steroidal anti-inflammatory drugs are commonly used, many women seek non-pharmacological alternatives due to limited effectiveness or adverse effects. Emerging evidence suggests that altered pelvic neurodynamics may contribute to dysmenorrheic pain.
This randomized controlled trial aims to evaluate the effectiveness of external pelvic nerve mobilization in reducing menstrual pain and associated symptoms among university women with primary dysmenorrhea. Participants aged 18-30 years will be randomly allocated to receive either external pelvic nerve mobilization or a sham manual therapy intervention across three consecutive menstrual cycles. Outcomes will include pain intensity, menstrual distress, quality of life, pelvic tenderness, analgesic consumption, and academic absenteeism.
详细描述
Primary dysmenorrhea is characterized by painful menstruation in the absence of identifiable pelvic pathology and affects a large proportion of young women. Pain is largely mediated by excessive prostaglandin release, uterine ischemia, and sensitization of pelvic neural pathways. Recurrent nociceptive input may lead to peripheral and central sensitization, exacerbating pain severity.
External pelvic nerve mobilization is a physiotherapy-based neurodynamic intervention designed to restore physiological mobility of pelvic and lumbosacral nerves, reduce neural mechanosensitivity, and modulate nociceptive signaling. Unlike internal pelvic techniques, this approach is entirely external, non-invasive, and suitable for young and student populations.
This single-blind, parallel-group randomized controlled trial will assess whether external pelvic nerve mobilization provides superior pain reduction and functional improvement compared with a sham intervention over three menstrual cycles.
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
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female university students aged 18-30 years
- •Regular menstrual cycles (24-35 days)
- •Clinically diagnosed primary dysmenorrhea
- •Average menstrual pain intensity ≥ 5 on Visual Analog Scale
- •Willingness to participate and provide informed consent
排除标准
- •Secondary dysmenorrhea (e.g., endometriosis, fibroids, pelvic inflammatory disease)
- •History of pelvic or spinal surgery
- •Neurological disorders
- •Current pregnancy or lactation
- •Current physiotherapy or manual therapy treatment
- •Contraindications to manual therapy
研究组 & 干预措施
Arm 1: External Pelvic Nerve Mobilization
Participants will receive standardized external neurodynamic mobilization techniques targeting the lumbosacral plexus and pudendal nerve pathways. Sessions will be delivered by trained women's health physiotherapists. Each session will last approximately 30 minutes and will be administered three times per menstrual cycle across three consecutive cycles.
干预措施: External Pelvic Nerve Mobilization (Other)
Arm 2: Sham Mobilization
Participants will receive non-therapeutic light manual contact over the lumbosacral and pelvic regions without neural gliding, joint movement, or tissue mobilization. Session duration and therapist interaction will match the intervention group.
干预措施: Sham Mobilization (Other)
结局指标
主要结局
Menstrual pain intensity
时间窗: During the first three days of menstruation at baseline and during the first three days of each menstrual cycle for three consecutive cycles (each cycle = 28 days).
Menstrual pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Participants will rate their average menstrual pain on a scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain intensity.
次要结局
- Analgesic consumption(Baseline (Cycle 0; prior menstrual cycle, defined as 28 days) and during menstruation for Cycles 1, 2, and 3 (each cycle = 28 days).)
- Academic absenteeism(Baseline (Cycle 0; prior menstrual cycle, defined as 28 days) and during menstruation for Cycles 1, 2, and 3 (each cycle = 28 days).)
- DAILY RECORD OF SEVERITY OF PROBLEMS(Baseline (Cycle 0; daily for a full 28-day menstrual cycle) and daily across Cycles 1, 2, and 3 (each cycle = 28 days).)
研究者
Raheela Kanwal
Assistant professor
University of Hail