NCT01899482 - Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

41

Conditions

Chronic Venous Insufficiency

Interventions

Manual Lymphatic DrainageOTHER

EducationBEHAVIORAL

Behavioral education.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Escola Superior de Saúde Dr. Lopes Dias

Castelo Branco, Portugal

Outcomes

Primary Outcomes

Quality of Life

Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).

Time frame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days)

Secondary Outcomes

Leg edema

Assessed by leg perimeter.

Time frame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).

Lower extremity symptoms

With Visual Analogue Scale was assessed: pain, fatigue, heaviness, itching, sKin irritation, cramps and other.

Time frame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).

Hemodynamic evidence of severity of chronic venous disease

Venous reflux and anterograde flow during manual leg compression, by duplex ultrasound in femoral vein, great saphenous vein, popliteal vein and small saphenous vein.

Time frame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).

Clinical severity of chronic venous insufficiency

Assessed by Venous Clinical Severity Score.

Time frame: Assessed at baseline (no intervention), after approximately one month, with an error of three days (10 sessions of manual lymphatic drainage, for experimental group) and after approximately two months from baseline (with an error of 5 days).