Physical Therapy in Lipedema Surgery

Completed

• Conditions: Lipedema; Assessment; Dermatologic Complication; Vascular Diseases
• Interventions: Other: modified CDT physical therapy protocol, based on Godoy's Method

• Registration Number: NCT05966779
• Lead Sponsor: University of Alcala

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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 293

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
modified CDT physical therapy protocol, based on Godoy's Method	modified CDT physical therapy protocol, based on Godoy's Method	A complete physical therapy assessment was done. All sociodemographic data were recruited as well as body mass index (BMI), the month of intervention, kind of surgery, extracted liters, psychological treatment, physical therapy sessions, pain, mobility, complications (seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema), compression, smoking, satisfaction with the treatment received. A modified CDT physical therapy protocol, based on Godoy's Method, was applied to all study participants. This protocol comprised of 1. Cervical Stimuli 15min 2. MLD based on Godoy 3. Mechanical lymphatic drainage with RA Godoy® device 4. Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage. 5. Skin care - before and after the bandages- and therapeutic education. 6. Put on compression garments 7. Active movement if possible.

Primary Outcome Measures

Name	Time	Method
Pain VAS scale	2018-2022	VAS

Secondary Outcome Measures

Name	Time	Method
edema resorption - volume	2018-2022	lower limb edema is measured
mobility - scale	2018-2022	1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement
patient satisfaction	2018-2022	binary outcome
complications reported - binary outcome	2018-2022	seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema

Trial Locations

Locations (1)

Ester Cerezo Tellez; 🇪🇸 Alcalá de Henares, Madrid, Spain