Physical Therapy in Lipedema Surgery

Vascular Diseases Clinical Trial

Official title:

Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966779
• Other study ID #: OE36/2023
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Assessment
• Dermatologic Complication
• Lipedema
• Vascular Diseases

Intervention

Other:
• modified CDT physical therapy protocol, based on Godoy's Method
modified CDT physical therapy protocol

Locations

Country	Name	City	State
Spain	Ester Cerezo Tellez	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS scale	VAS	2018-2022
Secondary	edema resorption - volume	lower limb edema is measured	2018-2022
Secondary	complications reported - binary outcome	seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema	2018-2022
Secondary	mobility - scale	1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement	2018-2022
Secondary	patient satisfaction	binary outcome	2018-2022