Non-inferiority of Compression Bandage Alone in Lower Extremity Lymphedema Management

Summary

Lymphedema is much more than a disease with edema. Impaired lymphatic drainage triggers adipose tissue deposition and fibrosis. Fibrosis causes lymphatic vessel dysfunction. Therefore, treatment of fibrosis is important. The gold standard of treatment for lymphedema is complex decongestive physiotherapy. In this treatment method consisting of two phases and four components in each phase, each component has its own effect. Compression is the main component of these components in terms of edema reduction. The effect of manual lymph drainage, another component, on edema and fibrosis is contradictory. Although there are studies evaluating fibrosis in lower extremity lymphedema in the literature, there is no study evaluating the effect of treatment on fibrosis and comparing two different methods evaluating fibrosis.

Research question: What is the effect of manual lymph drainage in addition to compression therapy on fibrosis, edema, skin and subcutaneous tissue thickness, and quality of life.

The primary aim of this study was to evaluate the effect of manual lymph drainage applied as an adjunct to compression therapy on fibrosis in individuals with lower extremity lymphedema. The secondary aim of the study was to evaluate the effect of manual lymph drainage in addition to compression therapy on skin and subcutaneous tissue thickness, edema and quality of life.

Patients with lower extremity lymphedema will be randomly allocated to the compression group and manual lymph drainage + compression group. Fibrosis in the tissues of the individuals will be evaluated by ultrasound and SkinFibrometer device, skin and subcutaneous tissue thickness will be evaluated by ultrasound, edema perimeter measurement will be converted to volume, and quality of life will be evaluated by Lymphedema Quality of Life Questionnaire-Lower Extremity before and after treatment. Individuals will be randomized to either 20 sessions of compression bandage or 20 sessions of compression bandage with manual lymph drainage. Both groups will include skin care and exercise components of complex decongestive physiotherapy.

This study will provide important data on whether manual lymph drainage is clinically necessary in the treatment of lower limb lymphedema.

Conditions

• Lower Extremity Lymphedema

Interventions

OTHER

Compression bandage

A multicomponent inelastic compression bandage will be applied to the patient. Skin care and simple exercises will be added to intervention

OTHER

Manual lymphatic drainage added to compression

Manual lymphatic drainage will be added to multicomponent inelastik compression bandage, skin care and simple exercises

Sponsors & Collaborators

• The Scientific and Technological Research Council of Turkey

  collaborator OTHER

• Abant Izzet Baysal University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2026-03-01

Completion

2026-04-01

Countries

• Turkey (Türkiye)

Study Locations