Complex Decongestive Applications in Patients With Lipedema

Completed

• Conditions: Lipedema
• Interventions: Other: Manual Lymph Drainage; Other: Bandaging

• Registration Number: NCT04492046
• Lead Sponsor: Gazi University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-09-02
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Status Verified: 2020-07
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-28
• Last Update Submitted: 2020-07-28
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complex Decongestive physiotherapy	Manual Lymph Drainage	All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.
Complex Decongestive physiotherapy	Bandaging	All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.

Primary Outcome Measures

Name	Time	Method
Limb Volume	Change from Baseline limb volume at 6 weeks	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.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Çankaya, Turkey