Complex Decongestive Applications in Patients With Lipedema

July 28, 2020 updated by: Gokhan Yazici, Gazi University

The Effect of Complex Decongestive Applications on Lower Extremity Limb Volume 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06650
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included in this study consisted of those who had a diagnosis of lipedema in the lower extremities, between the ages of 18-65.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complex Decongestive physiotherapy
All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline limb volume at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Gokhan Yazici, PhD, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lipedema

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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