Clinical trial NCT05966779: Physical Therapy in Lipedema Surgery
Official title: Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment
Lipedema
Vascular Diseases
Dermatologic Complication
Keywords: Lipedema, physical therapy,liposuction,complications,treatment,assessment
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Pain VAS scale
timeFrame: 2018-2022
Secondary outcomes:
measure: edema resorption - volume
timeFrame: 2018-2022
measure: complications reported - binary outcome
timeFrame: 2018-2022
measure: mobility - scale
timeFrame: 2018-2022
measure: patient satisfaction
timeFrame: 2018-2022
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Ester Cerezo Tellez
state: Madrid
Study officials:
References: