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The aim of this study is to evaluate the effect of cavitation ultrasound focused on localized adiposity and its effects associated with stereodynamic lymphatic drainage. The investigators aim also to know if this procedure will influence the biochemical profile of the individuals concerned, as well as whether it will be found difference between the group that will receive focused ultrasound cavitation associated with stereodynamic drainage and the group will receive only focused cavitation ultrasound.
This study will be a double-blind randomized clinical trial, preceded by a pilot study due to lack of data in the literature impossible to calculate the size of adequate sample.
The overall objective of the study is to evaluate the effect of cavitation ultrasound focadalizado in localized adiposity and its associated lymphatic drainage effects stereodynamic.
The specific objectives are:
Evaluate and compare the effects of focused ultrasound cavitation in reducing hypodermic layer and anthropometric measurements of women; To evaluate the acute and chronic effects of the technique; To evaluate the reduction in adipose tissue layer from the ultrasound image; Evaluate and compare the reduction of the fat layer through intergroup and intragroup photographic image; Evaluating and comparing serum biochemical parameters (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, glucose, urea and creatinine) of women undergoing focused ultrasound cavitation; Evaluate and compare the technical efficiency in group A (without stereodynamic drainage) and B (with stereodynamic drainage).
This study will be conducted with 28 volunteers, respecting the criteria for inclusion and exclusion previously cited by reading and signing of the free and clear consent. Participants will be divided into 02 groups randomly. Randomization will be performed by using the local random distribution www.random.org tool, in order to prevent the researcher to identify which intervention will be performed on each patient. The generation of sequence numbers shall be made by the researcher "blind" to the study, after the selection of patients for inclusion and exclusion criteria. The sequence numbers to be used for randomization will be kept confidential until such time as the intervention Participants will undergo a 4-week control period between the first (base) and the second evaluation (pre-treatment), so each participant It will be their own control, ensuring that the possible changes that may be found at the end of the project will be related to the procedure and not influenced by lifestyle habits. During the period the research subjects will be instructed not alterararem their respective routine activities.
08 sessions will be conducted Cavitational Focused Ultrasound in individual applications, once per week, total of 08 weeks of treatment. The first collection (pre-treatment) will be only to carry out the data collection.
Data collection will consist of:
Height: will be determined by the balance rule coupled with a degree in 1 mm, with the individual back to this, in an upright standing position, feet together, and trying to put the posterior surface of heels, pelvic and shoulder girdle contact instrument; Body weight will be measured through traditional mechanical scale with 100g graduation, with front man for the same, in the upright position, feet together, wearing light clothes and without shoes; Body Mass Index (BMI) - Based on height and weight will be held calculate BMI, kg ÷ height x height; Abdominal skin fold, used to estimate the percentage of body fat will be taken using caliper. It will be measured abdominal crease, having as anatomical reference umbilicus, plying up the region located 1 to 3 cm to the right of scar parallel to the longitudinal axis of the body; Waist circumference will be measured using the measuring tape positioned parallel to the ground, where the measurement is taken over previous iliac crests 5 cm above the previous iliac crests 10 cm above the iliac crest and waist earlier; Hip circumference, the tape measure is parallel to the ground and positioned in terms of points of trocantéricos right and left, while the individual will be assessed with feet together; Thigh circumference will also feature the same principles described above, but will be used as an indication of circumference changes that are unrelated to treatment, such as changes induced by weight loss.
Step 1: The evaluators will receive slides with 6 photos for each patient, in random order (will be photographs in black and white, not to interfere in the result). The evaluator will classify the images in the order of 1 to 2, being 1 before treatment, after treatment and 2 referring to the reduction of localized fat deposits in the abdominal region (it is expected that the treatment reduces the action of the abdominal region, so this sort order). They will receive 3 slides for each patient, each containing images of the respective regions measured: front, right profile and left profile.
Step 2: evaluators should classify the changes in the abdominal region, in one of the degrees of the scale below: 0% = no change; 1% - 25% = little change; 25-50% = was no change in terms of improvement, but nothing extremely significant; 50% or more = a change from the reduction of localized fat in the abdominal area is visible / improved considerably.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused ultrasound cavitation: Lipofocus | Active Comparator | The first group will receive only the application of focused ultrasound cavitation. |
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| Focused ultrasound and drainage: Lipofocus | Active Comparator | The second group will receive focused ultrasound cavitation followed by stereodynamic drainage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIPOFOCUS | Device | In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 Megahertz (MHz), and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random. |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Ultrasound Focused Cavitational reduce the layer of fat in the abdominal area abdominal region. | Eight weeks | |
| Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region. | Eight weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cinara LS Lima | Federal University of Health Science of Porto Alegre | Principal Investigator |
| Suélen A Kislowski | Federal University of Health Science of Porto Alegre | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| LIPOFOCUS | Device | In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 MHz, and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random . The procedure is followed by stereodynamic drainage, where it will be used a printhead comprising three ERAs (effective radiation area) of 15 Watt each time this procedure is calculated through the area (size of the area to be treated) divided by ERA (cm² head size). |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |