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

Study Overview
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Brief Summary
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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.

Official Title
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Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Other: Manual Lymphatic Drainage
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Lymphatic Drainage<br>One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month. | Other: Manual Lymphatic Drainage<br> <br> Behavioral: Education<br>* Behavioral education.<br>|
| Active Comparator: Control<br>One educational session in group. | Behavioral: Education<br>* Behavioral education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg edema | Assessed by leg perimeter. | 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. | 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. | 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. | 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). | 
| Calf muscle strength and ankle range of motion | Evaluated by Biodex system 3 pro isokinetic dynamometer. | Assessed at aseline (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) | 
| Sel-reported functional status | Evaluated by Portuguese version of Functional Status Questionnaire (FSQ). | Assessed at aseline (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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage