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Clinical Trials/NCT04492046
NCT04492046CompletedNot Applicable

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

Gazi University1 site in 1 country23 target enrollmentStarted: September 2, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
1
Primary Endpoint
Limb Volume

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gokhan Yazici

Principal Investigator

Gazi University

Study Sites (1)

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