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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: cavitation, whole body electromyostimulation
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.
Device: cavitation, whole body electromyostimulation
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.
Device: cavitation, whole body electromyostimulation
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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