Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasonic cavitation
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
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
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
40000HZ ultrasound cavitation
2600HZ ultrasound cavitation
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05039125
Brief Title
Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
Official Title
Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40000HZ ultrasound cavitation
Arm Type
Active Comparator
Arm 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.
Arm Title
2600HZ ultrasound cavitation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
ultrasonic cavitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Anthropometric measures
Description
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
Time Frame
2 moths after treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Maged M ElGoly
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between The Effects Of Different Frequencies Of Ultrasonic Cavitation On Abdominal Adiposity And Female Hormones In Polycystic Ovarian Syndrome
We'll reach out to this number within 24 hrs