An observational study in Assessment, Lipedema and Vascular Diseases, sponsored by University of Alcala. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Alcala · Observational
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:
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
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's enrollment of 293 is above the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →University of Alcala is the lead sponsor of 128 studies on the registry; 36 are open to participants now.
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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).
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Exclusion Criteria:
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.
Other: modified CDT physical therapy protocol, based on Godoy's Method
modified CDT physical therapy protocol
Pain Visual Analogue Scale
Pain assessed using the Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.
Time frame: Baseline, short-term (post-treatment), and 90 days follow-up
edema resorption - volume
lower limb edema is measured
Time frame: 2018-2022
complications reported - binary outcome
seroma, wound infection, chafing or risk of ulcer, pain, fibrosis, genital edema
Time frame: 2018-2022
mobility - scale
1- dependent to move/no improvement, 2-somewhat dependent/minor to medium improvement, 3- independent marked improvement
Time frame: 2018-2022
patient satisfaction
binary outcome
Time frame: 2018-2022
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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