Physical Therapy in Lipedema Surgery

NCT05966779 | Completed DMC

• 1 other identifier: OE36/2023
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

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

Conditions

Assessment; Lipedema; Vascular Diseases; Dermatologic Complication

Keywords

Lipedema, physical therapy,liposuction,complications,treatment,assessment

Outcome Measures

Primary Outcomes (1)

• Pain VAS scale

  VAS

  2018-2022

Secondary Outcomes (4)

• edema resorption - volume

  2018-2022

• complications reported - binary outcome

  2018-2022

• mobility - scale

  2018-2022

• patient satisfaction

  2018-2022

Study Arms (1)

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 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

Interventions

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

modified CDT physical therapy protocol

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• female subject who underwent a lipedema surgery
• recommendation of the surgeon to receive physical therapy

You may not qualify if:

• unilateral surgery
• lack of data in the clinical history
• only 1-2 physical therapy sessions

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Ester Cerezo Tellez

Alcalá de Henares, Madrid, 28823, Spain

Location

MeSH Terms

Conditions

Lipedema; Vascular Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD., Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: July 1, 2023
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

ES (1)