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

NCT ID: NCT05039125

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2021-08-02

Brief 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.

Detailed 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

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

40000HZ ultrasound cavitation

group A (n=15) received 40000HZ 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.

Group Type: ACTIVE_COMPARATOR

ultrasonic cavitation

Intervention Type: RADIATION

• 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

2600HZ 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.

Group Type: ACTIVE_COMPARATOR

ultrasonic cavitation

Intervention Type: RADIATION

• 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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Mohamed Maged M ElGoly

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

62

Identifier Type: -

Identifier Source: org_study_id