Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial (MLDCVI)

Technical University of Lisbon

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Other: Manual Lymphatic Drainage; Behavioral: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01899482

SFRH/BD/62673/2009

Details and patient eligibility

About

The purpose of this study is to compare functional status and quality of life of a group of patients with chronic venous insufficiency treated with manual lymphatic drainage with a group not treated with manual lymphatic drainage.

Investigators hypothesized that manual lymphatic drainage can improve:

• quality of life,
• functional status,
• calf muscle strength,
• ankle range of motion,
• edema,
• severity of disease,
• and symptoms.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnose of chronic venous insufficiency class C3-5 for Clinical-Etiological-Anatomical-Pathological classification (CEAP).

Exclusion criteria

• Severe cardiac insufficiency,
• Acute venous or arterial obstruction,
• Arterial insufficiency, renal insufficiency,
• Uncompensated thyroid dysfunction,
• Pregnancy, neoplastic pathology,
• Systemic or limb infection,
• Recent musculoskeletal injury in the lower limb,
• Peripheral neuropathy in the lower limb.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Manual Lymphatic Drainage

Experimental group

Description:

One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.

Treatment:

Behavioral: Education

Other: Manual Lymphatic Drainage

Control

Active Comparator group

Description:

One educational session in group.

Treatment:

Behavioral: Education