Complex Decongestive Applications in Patients With Lipedema

Lipedema Clinical Trial

Official title:

The Effect of Complex Decongestive Applications on Lower Extremity Limb Volume in Patients With Lipedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492046
• Other study ID #: Lipedema
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: July 2020
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Lipedema is a rare condition which almost exclusively affects women. The disease is characterized with bilateral, symmetric abnormal accumulation of subcutaneous fat and is often mistaken for simple obesity. In most patients, the hips, buttocks, thighs, knees, and lower legs are affected. Upper extremity involvement has been reported to be present in 80% patients. The hands and feet are never affected. The accumulation of subcutaneous fat and edema results in tenderness, sensitivity to touch and pressure and also pain. Patients also tend to bruise easily even after a minimal trauma. It has been reported that the complaint of pain increases with aging.There is no known cure for lipedema. However, conservative treatment with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy is used worldwide as a standard treatment regimen . The aim of this study is to investigate the effect of complex decongestive applications on lower extremity limb circumference and volume in patients with lipedema.

Description:

All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy Each patient received;

1. 45 minutes of manual lymph drainage on both lower extremities,

2. Moisturisation of the lower extremities,

3. Bandage application

Alongside this routine, the patients were advised to exercise (walk) regularly every day.

This treatment routine was continued until the patients were discharged from the clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being willing to participate in the study

• Being 18-65 years old

• Having a diagnosis of lower extremity lipedema

Exclusion Criteria:

• Having edematous disease in the lower extremity such as lymphedema or chronic venous insufficiency

Related Conditions & MeSH terms

• Lipedema

Intervention

Other:
• Manual Lymph Drainage
Manual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes.
• Bandaging
Multilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb Volume	In measurement of limb volume, the perometer was used. The device measures limb volume via infrared light and it has been reported to be a quick and reliable method. The device has a square frame which is used to surround the perimeter of the limb. The limb interrupts the emitted infrared beams that would normally be sensed by the light-sensing diodes in the two planes. Thus two perpendicular diameter measurements of the limb for the measured segment are provided. The device estimates the opposite two sides based on an elliptical cross-section.	Change from Baseline limb volume at 6 weeks