Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Assessment of pain intensity
研究概览
简要总结
Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia.
Patients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.
详细描述
Patients will be divided randomly into two groups equal in number:
Control group (Group A): It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity).
Study group (GroupB): It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). All females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study
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
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Women complain of secondary dyspareunia, diagnosed and referred by the gynecologist.
- •Multiparous women.
- •Their ages will range from 25-35 years.
- •Their body BMI will be less than 35 kg/m².
- •Their pain level on the VAS will be ≥
- •All the women were negative for vaginal infections caused by viruses, bacteria or fungi.
排除标准
- •Pregnancy
- •Malignancy.
- •The presence of an intrauterine device, vaginal infection, or skin/mucous lesions.
- •Diabetes mellitus.
- •Dermatological abnormalities on the skin at acupuncture point.
- •Severe uncontrolled cardiac patients or implanted cardiac rhythm devices.
- •Dyspareunia with endometriosis.
- •Fearing from electricity.
结局指标
主要结局
Assessment of pain intensity
时间窗: Ten weeks
Visual analogue scale (VAS) will be used to measure pain intensity for each female in both groups (A\&B). Each female will be asked to mark the point on the scale that represents her pain level.
Assessment of dyspareunia
时间窗: 10 Weeks
Marinoff Dyspareunia Scale will be used to evaluate vaginal and vulvar symptoms and pain related to sexual intercourse for both groups (A\& B) before and after the end of the treatment (10 weeks).
次要结局
- Assessment of sexual function(Ten weeks)
- Assessment of quality of life(Ten weeks)
研究者
Marwa gamal abdelrahman ahmed
Master student at Faculty of Physical Therapy, Cairo University
Cairo University