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OpenTrials
Completed

NCT Number: NCT05966779

Physical Therapy in 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

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Ester Cerezo Tellez

Alcalá de Henares, Madrid, 28823, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

modified CDT physical therapy protocol

Primary outcomes

  1. Pain VAS scale

    Time frame: 2018-2022

    VAS

Secondary outcomes

  1. edema resorption - volume

    Time frame: 2018-2022

    lower limb edema is measured

  2. complications reported - binary outcome

    Time frame: 2018-2022

    seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema

  3. mobility - scale

    Time frame: 2018-2022

    1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement

  4. patient satisfaction

    Time frame: 2018-2022

    binary outcome

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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