Physical Therapy in Lipedema Surgery

Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery

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

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Lipedema; Dermatologic Complication; Assessment
• Intervention / Treatment: Other: modified CDT physical therapy protocol, based on Godoy's Method

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 Type: Observational
• Enrollment (Actual): 293

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28823
      • Ester Cerezo Tellez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

females from undergon a surgical proceeding for lipedema in two private hospitals in Madrid and were treated in a private physical therapy center. After surgery they were recommended to receive CDT by their surgeons. All participants received the same physical therapy treatment. The study was approved by the Clinical Research Committee of Hospital Universitario Principe de Asturias (CEIm 36/2023).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; Cervical Stimuli 15min; MLD based on Godoy; Mechanical lymphatic drainage with RA Godoy® device; Compression therapy with multilayer and multicomponent bandages during the mechanical lymphatic drainage.; Skin care - before and after the bandages- and therapeutic education.; Put on compression garments; Active movement if possible.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS scale	VAS	2018-2022

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Lipedema, physical therapy,liposuction,complications,treatment,assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Connective Tissue Diseases; Vascular Diseases; Lipedema
• Other Study ID Numbers: OE36/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No