Lipedema
Conditions
Interventions
This is a randomized, controlled clinical trial with three arms and single-blind blinding. After initial assessment, 60 women diagnosed with lipedema will be randomly allocated, through simple randomi
Sponsors
Centro Universitário das Faculdades Associadas de ensino - FAE
Indústria Brasileira de Equipamentos Médicos
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: Female volunteers; aged between 18 and 42 years; diagnosed with lipedema in the lower limbs; agree to participate and sign the informed consent form
Exclusion criteria
Exclusion criteria: Pregnant women; individuals with hemophilia, bleeding disorders, or skin tissue abnormalities; individuals with rheumatological pathologies; individuals with diabetes mellitus or decompensated systemic metabolic disorders; those belonging to other research groups in the same study area and/or undergoing treatment for the pathology with another methodology; individuals with cancerous alterations; refusal to sign the informed consent form; health disorders known to be related to the onset of menopause and/or perimenopause; endocrine disorders not related to sex hormones but which are not adequately controlled; those who have undergone cosmetic surgery in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in pain associated with lipedema, assessed using the Visual Analogue Scale (VAS), is expected in pre- and post-intervention measurements;It is expected that the chronic inflammatory process will be attenuated, as assessed by measuring the levels of the inflammatory biomarkers IL-6 and IL-8, in pre- and post-intervention measurements;An improvement in quality of life is expected, which will be assessed using the SF-36 questionnaire, based on pre- and post-intervention scores;It is expected that the intensity of Lipedema symptoms will be reduced, which will be assessed using the QuASIL questionnaire, based on pre- and post-intervention scores | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the thickness of subcutaneous adipose tissue is expected, which will be assessed using diagnostic ultrasound with a linear transducer (frequency 6-18 MHz), in measurements of values ??obtained before and after the intervention;A reduction in body circumferences is expected, assessed through perimeter measurements with a measuring tape, in the pre- and post-intervention measurements;The aim is to evaluate the safety of the therapeutic intervention, verified through monitoring for possible adverse effects during the application of the treatment protocol | — |
Countries
Brazil
Contacts
Public ContactPatricia Brassolatti
Indústria Brasileira de Equipamentos Médicos
Outcome results
None listed