Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Change of menstrual complaints' severity
研究概览
简要总结
The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.
详细描述
The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.
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)
盲法说明
an independent researcher assigned the participants to one of the two study groups, by opening sealed envelopes containing serially ordered numbers. An independent assessor analyzed the patients' blood samples for hormonal profile and another assessor blinded to patients' allocation interviewed the patients for the questionnaire and assessed the weight.
入排标准
- 年龄范围
- 20 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women having PCOS.
- •25 ≤ BMI ≤ 30 Kg/m
- •Waist/hip ratio ≤ 0.
- •Women experiencing irregular menstrual cycles.
排除标准
- •Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
- •Having malignancy.
- •Presence of reproductive disorders unrelated to PCOS.
- •Presence of adrenal gland abnormalities.
研究组 & 干预措施
Diet group
Giving a low caloric diet
干预措施: Low-calorie diet (Other)
Visceral manipulation with diet group
Giving visceral manipulation added to a low-calorie diet
干预措施: Visceral manipulation with diet (Other)
结局指标
主要结局
Change of menstrual complaints' severity
时间窗: At baseline and after three months of the intervention.
The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function.
次要结局
- Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)(At baseline in the second day of menstruation and after three months of the intervention.)
- Change in weight(At baseline and after three months of the intervention.)
- Change in Body mass index (BMI)(At baseline and after three months of the intervention.)
研究者
Mahitab Mohammed Yosri Ibrahim
Lecturer of physical therapy for women's health
Cairo University