Clinical Trials Directory

Trials / Completed

CompletedNCT05966779

Physical Therapy in Lipedema Surgery

Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
293 (actual)
Sponsor
University of Alcala · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERmodified CDT physical therapy protocol, based on Godoy's Methodmodified CDT physical therapy protocol

Timeline

Start date
2023-07-01
Primary completion
2023-07-12
Completion
2023-07-12
First posted
2023-08-01
Last updated
2023-08-01

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05966779. Inclusion in this directory is not an endorsement.