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IRCT20250826067003N1 IRCT 2025-10-20 Islamic Azad University Evaluation of the effect of cavitation and energy therapy on localized obesity Evaluation of the effect of cavitation and energy therapy on localized obesity 2025-10-25 anticipated 110 Complete https://irct.ir/trial/85862 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Local obesity. Intervention 1: Intervention group: This group will undergo ultrasound cavitation treatment for 10 sessions, each session lasting 15 minutes(interval of 1 week/intervention period 10 weeks). This treatment will be performed using the RF Slimming Device – Model 3Max, made in South Korea. The treatment area (with localized fat) is determined and a conductive gel is applied. Cavitation is applied to the target area at an intensity of 8 degrees for about 10 minutes. Then, thermal RF is applied for 5 minutes to increase blood flow and facilitate the excretion of metabolites. Patients are required to follow a controlled diet and walk for 30 minutes daily to increase the excretion of fat metabolites. After each session, the patient is monitored and possible side effects (redness, skin warmth) are checked. RF creates radiofrequency heat waves in the subcutaneous layers, leading to increased metabolism of adipose tissue and stimulation of collagen synthesis. Cavitation (low-intensity ultrasound) causes microscopic bubbles to form in adipose tissue, which destroy fat cells (adipocytes) through mechanical destruction. Finally, the released fatty acids enter the bloodstream and are excreted through natural metabolism or physical activity. Intervention 2: Control group: In this group, the participants will be subjected to Energy Therapy intervention. This method is of the Therapeutic Touch type, which is based on the mental focus of the therapist on the vital energy flow of the body. Performance environment: a quiet room with soft light and constant temperature (24-25°C). Therapist: a person trained in the field of energy therapy (with a valid certificate in Therapeutic Method Touch). Implementation method: The therapist is placed at a distance of about 5 to 10 cm from the patient's body and performs hand movements slowly and intermittently in the abdomen, with the aim of adjusting and harmonizing the body's energy field. Physical contact: minimal and non-invasive (short-term surface contact in necessary cases). Duration of each session: 30 minutes. The intervention is purely mental-energetic. The goal of the intervention: to create an energy balance in the abdominal area in order to investigate possible effects on fat metabolism. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information available.
public Mohammad Javad Heidari
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2660 2642 mojavad2030@gmail.com Islamic Azad University scientific Mohammad Javad Heidari
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran
Tehran Iran (Islamic Republic of) 1949635881 +98 21 2660 2642 mojavad2030@gmail.com Islamic Azad University Iran (Islamic Republic of) Body mass index greater than 30 kg/m2 18 years 60 years Both Severe diabetes Abdominal hernia E66.9 Obesity, unspecified Treatment - Devices Placebo Intervention group: This group will undergo ultrasound cavitation treatment for 10 sessions, each session lasting 15 minutes(interval of 1 week/intervention period 10 weeks). This treatment will be performed using the RF Slimming Device – Model 3Max, made in South Korea. The treatment area (with localized fat) is determined and a conductive gel is applied. Cavitation is applied to the target area at an intensity of 8 degrees for about 10 minutes. Then, thermal RF is applied for 5 minutes to increase blood flow and facilitate the excretion of metabolites. Patients are required to follow a controlled diet and walk for 30 minutes daily to increase the excretion of fat metabolites. After each session, the patient is monitored and possible side effects (redness, skin warmth) are checked. RF creates radiofrequency heat waves in the subcutaneous layers, leading to increased metabolism of adipose tissue and stimulation of collagen synthesis. Cavitation (low-intensity ultrasound) causes microscopic bubbles to form in adipose tissue, which destroy fat cells (adipocytes) through mechanical destruction. Finally, the released fatty acids enter the bloodstream and are excreted through natural metabolism or physical activity. Control group: In this group, the participants will be subjected to Energy Therapy intervention. This method is of the Therapeutic Touch type, which is based on the mental focus of the therapist on the vital energy flow of the body. Performance environment: a quiet room with soft light and constant temperature (24-25°C). Therapist: a person trained in the field of energy therapy (with a valid certificate in Therapeutic Method Touch). Implementation method: The therapist is placed at a distance of about 5 to 10 cm from the patient's body and performs hand movements slowly and intermittently in the abdomen, with the aim of adjusting and harmonizing the body's energy field. Physical contact: minimal and non-invasive (short-term surface contact in necessary cases). Duration of each session: 30 minutes. The intervention is purely mental-energetic. The goal of the intervention: to create an energy balance in the abdominal area in order to investigate possible effects on fat metabolism. Waist circumference. Timepoint: Before the intervention and 2 weeks after the intervention. Method of measurement: Non-stretchable measuring tape. Islamic Azad University Approved 2025-08-27 Ethics Committee of the Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayane Blvd, Amir Pabarja St, Golhak Road, Dr. Shariati St, Tehran Tehran Tehran Iran (Islamic Republic of)