Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039125
• Other study ID #: 62
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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 ? 0.85. Their LH/FSH ratio was = 1.5. They were from the same social class.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Radiation:
• ultrasonic cavitation
From a standing position, each participant's abdomen was divided transversally into three sections; 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric measures	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	2 moths after treatment