Evaluation of the Effectiveness of Manual Lymphatic Drainage in Young Women With Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
This pilot clinical trial aims to evaluate the effectiveness of manual lymphatic drainage (MLD) in reducing symptoms associated with primary dysmenorrhea in young women. Primary dysmenorrhea is a common gynecological condition characterized by intense pelvic pain during menstruation, often accompanied by fatigue, headache, and sleep disturbances. Despite its high prevalence, it is frequently underestimated, negatively impacting quality of life and daily activities.
The intervention consists of three monthly sessions of MLD performed during the late luteal phase, prior to menstruation. Outcome measures include pain intensity, abdominal circumference, pressure pain threshold, sleep quality, and health-related quality of life.
详细描述
Primary dysmenorrhea (PD) is defined as menstrual pain of uterine origin occurring in the absence of pelvic pathology. It typically affects adolescents and young women with regular ovulatory cycles. The pathophysiology involves hormonal changes during the late luteal phase, leading to increased prostaglandin synthesis, uterine hypercontractility, ischemia, and heightened nociceptive sensitivity.
Non-pharmacological interventions such as physical therapy techniques have shown promising results in alleviating symptoms. Manual lymphatic drainage (MLD), based on the Vodder method, uses gentle, rhythmic maneuvers to stimulate lymphatic flow, reduce tissue congestion, and promote parasympathetic activation, potentially improving pain perception and associated symptoms.
This study will assess whether MLD reduces pain intensity, abdominal swelling, and improves sleep quality and overall quality of life in women with PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-25 years
- •Confirmed diagnosis of primary dysmenorrhea
- •Regular menstrual cycles
- •Ability to provide informed consent
排除标准
- •Secondary dysmenorrhea
- •Use of hormonal contraceptives
- •Presence of pelvic pathology (endometriosis, polycystic ovary syndrome, fibroids)
- •Irritable bowel syndrome
- •Use of analgesics or anti-inflammatory drugs within 12 hours prior to intervention
- •Any therapy for dysmenorrhea in the previous month
- •Pregnancy or suspected pregnancy
- •Irregular menstrual cycles
研究组 & 干预措施
Manual Lymphatic Drainage Group
All enrolled participants (N=20) will receive the intervention consisting of manual lymphatic drainage (MLD) following the Vodder method. The treatment will be applied during the late luteal phase (5-7 days before menstruation) in three consecutive menstrual cycles. Each session will last approximately 30-45 minutes and will include preparatory maneuvers (terminus, solar plexus, inguinal chains) and abdominal drainage sequence. No control group is included in this pilot study.
干预措施: Manual Lymphatic Drainage (MLD) (Other)
结局指标
主要结局
VAS
时间窗: baseline assessment, in the menstrual assessment of the first, second, and third months, and in the follow-up (fourth month)
Change in pain intensity measured by Visual Analog Scale (VAS). Visual Analog Scale (0-10 cm) to assess menstrual pain intensity. Scores are classified as mild dysmenorrhoea (1-3 points), moderate dysmenorrhoea (4-7 points) and severe dysmenorrhoea (8-10 points).
次要结局
- Pressure Pain Threshold (Algometry)(pre and post-intervention measurement in first month, pre and post-intervention measurement in the second month, pre and postintervention measurement in the third month, and in forth month (follow up))
- Abdominal Circumference (Circumferential Measurement)(second day of menstruation in the first month (baseline), second day of menstruation in the second month, second day of menstruation in the third month, and second day of menstruation in the fourth month (follow-up))
- Pittsburgh Sleep Quality Index questionnaire.(baseline assessment, post intervention in third month, and fourth month (follow-up))
- Health-Related Quality of Life (EQ-5D-5L)(baseline assessment, post intervention in third month, and fourth month (follow-up))
- Dysmenorrhea Severity (WaLIDD Score)(baseline assessment, post intervention in third month, and fourth month (follow-up))
- Andersh and Milsom dysmenorrhoea scale(baseline assessment, post intervention in third month, and fourth month (follow-up))
- Menstrual Symptom Questionnaire (MSQ)(baseline assessment, post intervention in third month, and fourth month (follow-up))
研究者
Edurne Úbeda D'Ocasar
Doctor
Camilo Jose Cela University