- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307898
Cavitaion vs W-BEMS on Central Obesity (w-bems)
December 19, 2025 updated by: Hadeer Elsayed Abdelrazik Elsayed Ramadan, Cairo University
Cavitation Versus Whole-Body Electromyostimulation on Infilamatory Markers in Centeral Obesity
The purpose of this study is to compare the effects of ultrasound cavitation and whole-body electromyostimulation (WB-EMS) on inflammatory markers in individuals with central obesity.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Sixty individuals with central obesity were recruited from private clinics.
And underwent a screening process to determine their eligibility based on the inclusion and exclusion criteria.
Eligible participants were informed about the study details, procedures, potential risks, and benefits before obtaining written informed consent
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Qalyubia Governorate
-
Cairo, Qalyubia Governorate, Egypt, 13611
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults aged 18-50 years.
- Individuals diagnosed with central obesity, defined as a waist circumference greater than 102 cm in men and 88 cm in women.
- Participants with a stable body weight for at least three months prior to the study.
- No engagement in regular physical activity or weight loss programs in the past six months.
- Willingness to adhere to study protocols and attend all scheduled sessions.
Exclusion Criteria:
Individuals with chronic diseases other than obesity-related conditions, such as cardiovascular disease, diabetes, or severe hypertension.
- Pregnant or lactating women.
- Individuals with implanted electronic devices (e.g., pacemakers).
- Participants with dermatological conditions or skin infections in the treatment area.
- Individuals undergoing medication that may affect fat metabolism or inflammatory markers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A (Study group)
Participants in this cohort were administered localized ultrasound cavitation treatments.
Each session was approximately 30 minutes in duration, with treatments scheduled twice a week.
In addition, participants received mediterranean diet
|
The duration of the study was set for 12 weeks.
Assessments were meticulously conducted at both the baseline and the conclusion of the study period to evaluate outcomes across the different groups.
|
|
Experimental: group B (Study group)
: Participants assigned to this cohort underwent whole- body electromyostimulation (WB-EMS) therapy.
These sessions were 20 minutes long, also occurring twice weekly.
Participants also received mediterranean diet.
|
The duration of the study was set for 12 weeks.
Assessments were meticulously conducted at both the baseline and the conclusion of the study period to evaluate outcomes across the different groups.
|
|
Sham Comparator: Group C (Control Group)
Participants in this control group receive mediterranean diet.
Additionally, they participated in all assessment procedures, ensuring a comprehensive comparative analysis.
|
The duration of the study was set for 12 weeks.
Assessments were meticulously conducted at both the baseline and the conclusion of the study period to evaluate outcomes across the different groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory Markers
Time Frame: 3 Monthes
|
Measurement of changes in levels of Tumor Necrosis Factor-alpha (TNF-alpha), and Interleukin-6 (IL-6) using ELISA (Enzyme-Linked Immunosorbent Assay) kits.
|
3 Monthes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist Circumference
Time Frame: 3 Monthes
|
Will be measured at the level of the iliac crest using a standard measuring tape to assess changes in central adiposity.
|
3 Monthes
|
|
Body Weight
Time Frame: 3 Monthes
|
Standard clinical scales to measure body weight at each visit to track changes over the study period.
|
3 Monthes
|
|
Body Mass Index (BMI)
Time Frame: 3 Monthes
|
Will be calculated using measured height and weight (kg/m²) to observe changes in overall body mass classification.
|
3 Monthes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2024
Primary Completion (Actual)
November 5, 2024
Study Completion (Estimated)
January 4, 2026
Study Registration Dates
First Submitted
August 26, 2025
First Submitted That Met QC Criteria
December 19, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/005581
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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