Physical Therapy in Lipedema Surgery

• Sponsor: University of Alcala (Other)
• Overall Status: Completed
• CT.gov ID: NCT05966779
• Collaborator: (none)
• Enrollment: 293
• Location: 1
• Actual Duration (Days): 11
• Patients Per Site Per Month: 810.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Assessment; Lipedema; Vascular Diseases; Dermatologic Complication	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 Design

• Study Type: Observational
• Actual Enrollment: 293 participants
• Observational Model: Ecologic or Community
• Time Perspective: Retrospective
• Official Title: Physical Therapy Intervention in the Immediate Postoperative Phase of Lipedema Surgery
• Actual Study Start Date: Jul 1, 2023
• Actual Primary Completion Date: Jul 12, 2023
• Actual Study Completion Date: Jul 12, 2023

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. Pain VAS scale [2018-2022]

   VAS

Secondary Outcome Measures

1. edema resorption - volume [2018-2022]

   lower limb edema is measured

2. complications reported - binary outcome [2018-2022]

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

3. mobility - scale [2018-2022]

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

4. patient satisfaction [2018-2022]

   binary outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ester Cerezo Tellez	Alcalá de Henares	Madrid	Spain	28823

Sponsors and Collaborators

• University of Alcala

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ester Cerezo-Téllez, PhD., Professor, University of Alcala
• ClinicalTrials.gov Identifier: NCT05966779
• Other Study ID Numbers: OE36/2023
• First Posted: Aug 1, 2023
• Last Update Posted: Aug 1, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ester Cerezo-Téllez, PhD., Professor, University of Alcala: Lipedema, physical therapy,liposuction,complications,treatment,assessment
• Additional relevant MeSH terms: Vascular Diseases; Lipedema

Study Results

No Results Posted as of Aug 1, 2023