Effect of Transcutaneous Tibial Nerve Stimulation on Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of Menstrual pain intensity
研究概览
简要总结
This study will be conducted to evaluate the effect of Transcutaneous Tibial Nerve Stimulation (TTNS) on primary dysmenorrhea.
详细描述
Primary dysmenorrhea is a common, disregarded, underdiagnosed, and inadequately treated complaint of both young and adult females. It negatively impacts the quality of life of young females, forming the main reason behind their absenteeism from school or work, and causing limitation of daily activities and psychological stress.
The Transcutaneous Tibial Nerve Stimulation (TTNS) is a rather new method acclaimed to be viable for chronic pelvic pain management. As it uses surface electrodes, it can be self-administrated by patients. Research is lacking regarding the effect of TTNS on primary dysmenorrhea. Thus, this study will be designed to examine the effect of TTNS on menstrual pain and distress as well as quality of life in females with primary dysmenorrhea. Study results will have valuable benefits in the physical therapy field, scientific research and medical and health organizations.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with a regular menstrual cycle, experiencing primary dysmenorrhea, confirmed by history and clinical diagnosis.
- •Females aged between 18 and 35 years.
- •Their BMI ranging from 20 to 29.9 kg/m².
排除标准
- •Females engaging in regular physical exercises prior to the study course.
- •A history of abdominal or pelvic surgery.
- •Pelvic pathologies or diseases (e.g., polycystic ovary syndrome, endometriosis, adenomyomas, or uterine fibroids).
- •Malignant or benign neoplasms in the uterus.
- •Chronic diseases, including diabetes and/or rheumatoid arthritis.
- •Presence of metal implants or pacemakers.
- •Any contraindications to the use of electrical stimulation (e.g., open wounds, some skin conditions…. etc.).
结局指标
主要结局
Assessment of Menstrual pain intensity
时间窗: 3 months
Using the Visual Analog Scale (VAS), each female will be asked to rate her menstrual pain intensity by placing a mark along the line that corresponds to their perceived pain level now. The distance from the "no pain" end to the female's mark will be then measured in centimeters to quantify the pain intensity. A higher value indicates greater pain intensity.
Assessment of Menstrual Distress
时间窗: 3 months
Using the Menstrual Distress Questionnaire (MEDI-Q), each participant will report physical, emotional, and social symptoms experienced during menstruation over the past 12 months and rate their impact on daily functioning and quality of life. The questionnaire uses a Likert scale to evaluate symptoms from the most recent cycle, and a total score is obtained by summing responses. Higher scores indicate greater menstrual distress and more substantial psychological and physical effects.
Assessment of Menstrual symptoms
时间窗: 3 months
Using the WaLIDD score, each female will be asked to answer questions by putting a score regarding five key factors related to primary dysmenorrhea: Working ability, Location of pain, Intensity of pain, Days of pain, and the presence of Dysmenorrhea. Each factor is scored based on the female's experience during their menstrual cycle. The scores from all factors are combined to produce a total score, with a higher score indicating greater severity and impact of dysmenorrhea.
次要结局
- Assessment of Quality of Life(3 months)
研究者
Aya Atef Mahmoud Sonbol
Principal Investigator
Cairo University