Effects of Ultrasound Cavitation Focused on Located Adiposity
Condition: Subcutaneous Fat
MeSH terms: Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

        -  Questionnaire of habitual physical activity Baecke - in the base period will be asked
           participants to answer this quiz to knowledge of their routine physical activity;

        -  Perimetry - anthropometric measurements will be measured by a previously trained
           evaluator. During the measurement of the circumference of the tape will be adjusted to
           the body, directly on the skin in order to provide more reliable measurements possible,
           without the occurrence of tape pressure on subcutaneous tissue causing deformity. These
           data will be verified in four stages: pre-treatment, before the first session after the
           first session and after the eighth treatment session. They will be measured:

      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.

        -  Bioimpedance - Evaluations shall be performed by a professional with training and
           experience in this type of analysis. Obtaining the bioimpedance will take place in two
           stages: in the base period (pre-treatment) and after the end of treatment (after the
           eighth session). For the examination, it will be used Maltron BF-900 model system and
           will be adopted the protocol recommendations proposed by the European Society for
           Clinical Nutrition and Metabolism: To assess body mass and height of the individual at
           the time of examination; Fasting individual and not drink alcohol for at least 8 hours;
           Urinate before the exam; Not perform physical exercise in the eight hours before the
           test; No injury to the skin where the electrode will be; Clean the skin with alcohol;
           Position the electrodes always on the same side of the body; Minimum 5 cm distance
           between the electrodes; Separate arms of the trunk for 30 ° and 45 ° legs apart; The
           environment duty will be neutral (no electric or magnetic field); It should be observed
           body shape for the risk of any possible anomaly (edema, amputation, atrophy, scoliosis,
           dystrophy); When prostheses or implants, is measured on the opposite side (KYLE et al,
           2004); You can not use metal objects during the examination as earrings, bracelets,
           watches and the like; There may be conducted in subjects who have pacemaker and who are
           in pregnancy.

        -  Ultrasound diagnosis - will be used to analyze and measure the hypodermic layer of the
           assessed region. This will be measured by a professional with training and experience in
           this type of evaluation. The evaluator will collect the images in the basic period (4
           weeks before the start of treatment) before the first and after the last login session.
           The results will be examined by a software in order to assess the thickness and
           statistics of the images defined by the image of ultrasound. To collect the individual
           will be in the supine position, the head is positioned above the navel and the fat
           thickness is measured from the inner layer of the skin to the aponeurosis of the rectus
           abdominis muscle in the middle of the Alba line area. The fat thickness measurement is
           performed with linear probe (7.5 MHz) with a depth of 4 to 5 cm.

        -  Blood collection - The analyzes will be performed on serum obtained by venipuncture,
           after an overnight fast of 12 hours. 02 will be held series of biochemical assessment by
           patient, where each collection will last for a maximum of 30 seconds. The first sample
           time is performed at baseline, i.e., before the control period. The second collection
           will be held after the end of treatment Focused Ultrasound Cavitational. After
           harvesting, the material is centrifuged at 3500 rpm / 10 minutes and then the analysis
           will be performed. Samples will be collected by a person trained for this, with latex
           glove use. They will be analyzed: total cholesterol, triglycerides, HDL cholesterol, LDL
           cholesterol, glucose, urea and creatinine.

        -  Photo documentation - To carry out the photos, there will be a standard procedure in
           order to maintain quality, the angle and the light always the same, so that the observed
           results can be compared reliably. Initially, patients using swimsuits, will be
           photographed standing in front and lateral planes (both sides) parallel to the plane of
           the camera sensor. The camera is mounted on the tripod, level and horizontal position,
           with the 105mm lens will be placed in proper height for framing the abdominal region,
           and at a distance of 1 meter. The flash is mounted on the hot shoe of the camera, set in
           TTL mode with the driven diffuser and will have its head directed forward. The camera
           will be displayed in manual mode, with f5.6 aperture, shutter speed to 1/60 second and
           ISO 200. The images will be taken in the base period and after the treatment and will be
           recorded in RAW format. The computational treatments on the images will be made in
           batch, so that all images suffer the same treatment and will be transformed into shades
           of gray. For image analysis, randomization of the resulting photographs will be held,
           and they will be delivered to two blind evaluators (physiotherapists) who will be
           invited to participate in the project to carry out this analysis. They will not know
           which patient images belong, or what the correct order of application of images. The
           evaluation will be as follows: both receive the photos in random order and will have to
           put them in progression order of the sessions, in 2 times: before and after treatment.
           After the correct organization, assess images qualitatively. Importantly, the designated
           evaluator will be a person with extensive knowledge about the procedure. The
           photographic analysis will be performed in two stages:

      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.
    

Intervention name(s): LIPOFOCUS; LIPOFOCUS
Intervention type(s): Device; Device
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lipolysis; Subcutaneous Fat, Abdominal/metabolism; Subcutaneous Fat, Abdominal/ultrasonography; High-Intensity Focused Ultrasound Ablation/methods; Waist Circumference; Pilot Projects; Subcutaneous Fat; High-Intensity Focused Ultrasound Ablation; Adiposity