Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2017
Links
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INTERVENTION: All intervention methods will be performed with 18 women, 9 from the group who do not take oral contraceptives (NG) and 9 who take oral contraceptives (GAH), which will be compared to each other. Protocol for evaluation of fibrous edema (PAFEG): This instrument consists of identification, anamnesis, physical examination through inspection and palpation, classification of FEG in mild, moderate and severe degree and tactile sensitivity test (Semmes ‐ Weinstein monofilaments). It was validated by Meyer et. Al., In 2005, in a study conducted at Potiguar University, in Rio Grande do Norte, Brazil, with 30 women with FEG. This evaluation will be performed prior to the ultrasound treatment sessions and after the completion of these sessions. Photogrammetry: The volunteers will be photographed in the orthostatic position, in the posterior plane, with the arms along the body and in a marked base on the ground. The camera will be placed on a tripod level at the height of the sacrum, 1 meter away from the wall, with the patient in front of the posturometer. The photographic records will be made with and without gluteal contraction, to visualize the degree of FEG classification (Mendonça, 2009). This evaluation will be performed prior to the ultrasound treatment sessions and after the completion of these sessions. Thermography: The thermographic camera used will be the Flir C2 model, which has high performance for thermal analysis and creates accurate images with temperature variations. It is a sensitive diagnostic tool that checks the surface temperature of the skin as a reflection of normal or abnormal physiology. Captures the temperature range from ‐10 ° C to 150 ° C, with an accuracy of ± 2 ° C or ± 2%. This evaluation will be performed prior to the ultrasound treatment sessions and after the completion of these sessions. Ultrasound, Diagnostic Avatar IV (KLD): The treatment of EGF will be carried out with the Device E01.370.350.600.630 E01.370.350.800 E02.565.280.945 SP5.001.047.133 CONDITION: Diseases of the skin and subcutaneous tissue ; L00‐L99 L00‐L99 PRIMARY OUTCOME: Improvement of the FEG appearance after the ultrasound sessions, evaluated through subjective physical examination of the PAFEG and graduation in the photographic records, using the Nurnberger‐Muller scale (zero stage: there is no appearance of furrows in the lying and standing positions; 1: there is no standing or lying evidence, but the skin presents a "mattress" appearance; stage 2: is evident in the standing position and does not appear when lying down; and stage 3: EGF is evidenced spontaneously both standing and lying down).; Women who use hormonal contraceptives are expected to perform better than women who do not. SECONDARY OUTCOME: Finding a change in the temperature of the area that was treated with ultrasound immediately after the application of the same. Through the thermographic records, the average gluteal temperature is expected to be reduced. Observation of the intensity that presents better results in the treatment of EGF, through graduation by the photographic records. The right gluteus, which was treated with 2.5W / cm2 intensity, is expected to have a lower grade than the left one, with an intensity of 1.0W / cm2. ; INCLUSION CRITERIA: Female subjects; Age between 20 and 30 years; Carriers of fibrous integumentary dysfunction; Users of hormonal contraceptive pill for the GA group; And not users of hormonal contraceptive pill for the GN group; without children; That are not undergoing esthetic treatment at the moment.
Epistemonikos ID: 59d72c0a2c24c50ed7a57728afc979155cc7fc4e
First added on: Aug 23, 2024