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

Cairo University (CU)

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Radiation: ultrasonic cavitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05039125

62

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

40000HZ ultrasound cavitation

Active Comparator group

Description:

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.

Treatment:

Radiation: ultrasonic cavitation

2600HZ ultrasound cavitation

Active Comparator group

Description:

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.

Treatment:

Radiation: ultrasonic cavitation