Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Assessment
- Sponsor
- University of Alcala
- Enrollment
- 293
- Locations
- 1
- Primary Endpoint
- Pain VAS scale
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Ester Cerezo-Téllez
PhD., Professor
University of Alcala
Eligibility Criteria
Inclusion Criteria
- •female subject who underwent a lipedema surgery
- •recommendation of the surgeon to receive physical therapy
Exclusion Criteria
- •unilateral surgery
- •lack of data in the clinical history
- •only 1-2 physical therapy sessions
Outcomes
Primary Outcomes
Pain VAS scale
Time Frame: 2018-2022
VAS
Secondary Outcomes
- mobility - scale(2018-2022)
- edema resorption - volume(2018-2022)
- patient satisfaction(2018-2022)
- complications reported - binary outcome(2018-2022)