Complex Decongestive Applications in Patients With Lipedema

NCT04492046 | Completed

• 1 other identifier: Lipedema
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema

Keywords

Lipedema; Manual lymph drainage; Complex Decongestive Physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Complex Decongestive physiotherapy

All participants included in the study were included in a treatment protocol consisting of Complex Decongestive physiotherapy.

Other: Manual Lymph Drainage; Other: Bandaging

Interventions

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.

Complex Decongestive physiotherapy

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.

Complex Decongestive physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Being willing to participate in the study
• Being 18-65 years old
• Having a diagnosis of lower extremity lipedema

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, Çankaya, 06650, Turkey (Türkiye)

Location

Related Publications (1)

• Volkan-Yazici M, Yazici G, Esmer M. The Effects of Complex Decongestive Physiotherapy Applications on Lower Extremity Circumference and Volume in Patients with Lipedema. Lymphat Res Biol. 2021 Feb;19(1):111-114. doi: 10.1089/lrb.2020.0080. Epub 2020 Oct 30.

  PMID: 33124947 DERIVED

MeSH Terms

Conditions

Lipedema

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gokhan Yazici, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 30, 2020
• Study Start: September 2, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)