Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Anthropometric measures
研究概览
简要总结
Thirty women diagnosed with PCOS had participated in the study. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages were from 20-35 years. Their BMI was from 30 - 35 kg/m². Their waist/hip ratio was ˃ 0.85. Their LH/FSH ratio was ≥ 1.5. They were recruited randomly from the outpatient clinic of gynecology in Minya governorate hospital. They were randomly assigned into two groups equal in number: (A and B); group A (n=15) received 40000HZ ultrasound cavitation, group B (n=15) received 2600HZ ultrasound cavitation. Treatment time was 30 minutes /sessions, 3 times/ week for two months. Both groups (A and B) received a low caloric diet (1200 Kcal/day). All participants had their medical treatment as prescribed by the physician.
详细描述
Participants in both groups were told to follow a low calorie diet (1200 Kcal/day) tailored to their specific needs (low in fat (15%), high in complex carbs (55%), and adequate in protein) (30 percent ) (11).
The application procedure of ultrasound cavitation for both groups (A and B):-
- Each participant in both groups (A and B) received instructions on the treatment techniques as well as the benefits of the USFC.
- To improve lymphatic drainage, each subject was encouraged to consume one liter of water before and after the therapy sessions.
- Each participant was urged to empty her bladder before beginning each treatment session so order to remain comfortable and relaxed throughout the session.
- From a standing position, each participant's abdomen was divided transversally into three sections; see fig (1) 1- Part I: from the xiphoid process to 3cm above the umbilicus, 2- Section II: from 2cm below the umbilicus to the pubic bone, and vertically to the linea alba, each part was separated into right and left segments, resulting in a total of 6 abdominal segments.
- Part III: 3cm above the umbilicus to 2cm below the umbilicus
- After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head.
- The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased.
- The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes.
- After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton.
For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months.
For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulligravida women with PCOS complaining of at least one year of infertility. They suffered from amenorrhea or oligo-menorrhea and subcapsular follicles. Their ages ranged from 20-35 years. Their BMI ranged from 30-35 kg/m². Their waist/hip ratio was ˃ 0.
- •Their LH/FSH ratio was ≥ 1.
- •They were from the same social class.
排除标准
- •history of heart disease, high cholesterol, l iver or kidney diseases, diabetes mellitus, hypertension, pregnancy, scarring, hernias, or skin diseases in the abdominal region that prevent the application of ultrasound cavitation
结局指标
主要结局
Anthropometric measures
时间窗: 2 moths after treatment
Weight-Height scale was used for each participant of the two studied groups (A \& B) before and after the study to measure the weight and height
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
professor
Cairo University