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Clinical Trial Summary

The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery. The main question it aims to answer are: - if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days - if the treatment is effective on preventing complications of these participants after surgery Participants have been treated in the lasts years and authors recover information of the effects of the treatment. Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received


Clinical Trial Description

Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery. Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction. A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05966779
Study type Observational
Source University of Alcala
Contact
Status Completed
Phase
Start date July 1, 2023
Completion date July 12, 2023

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