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OpenTrials
Completed

NCT Number: NCT04492046

Complex Decongestive Applications in Patients With Lipedema

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Çankaya, 06650, Turkey (Türkiye)

About this study

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

  • 45 minutes of manual lymph drainage on both lower extremities,
  • Moisturisation of the lower extremities,
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymph Drainage

Other

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

Other

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.

Primary outcomes

  1. Limb Volume

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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