Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL

Summary

The main scientific objective of this multicentric double-blinded randomised controlled trial entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the relationship between different variables of lymphoedema at baseline

Conditions

• Breast Neoplasm
• Lymphedema

Interventions

OTHER

Information

During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

OTHER

Skin care

The skin is hydrated during the session. If wounds are present, the wound is cared.

OTHER

Compression therapy

During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

OTHER

Fluoroscopy-guided MLD

Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors

OTHER

Traditional MLD

Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin.

OTHER

Placebo MLD

During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.

Sponsors & Collaborators

• Agentschap voor Innovatie door Wetenschap en Technologie

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Nele Devoogdt, PhD · University of Leuven - KU Leuven and University Hospitals Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2020-03-31

Completion

2020-09-30

Countries

• Belgium

Study Locations