Chronic Venous Insufficiency
Conditions
Keywords
Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage
Brief summary
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.
Interventions
OTHERManual Lymphatic Drainage
BEHAVIORALEducation
Behavioral education.
Sponsors
Fundação para a Ciência e a Tecnologia
Escola Superior de Saúde Dr. Lopes Dias, Portugal
Technical University of Lisbon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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) | Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity symptoms | 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). | With Visual Analogue Scale was assessed: pain, fatigue, heaviness, itching, sKin irritation, cramps and other. |
| Hemodynamic evidence of severity of chronic venous disease | 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). | Venous reflux and anterograde flow during manual leg compression, by duplex ultrasound in femoral vein, great saphenous vein, popliteal vein and small saphenous vein. |
| Leg edema | 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). | Assessed by leg perimeter. |
| Calf muscle strength and ankle range of motion | 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) | Evaluated by Biodex system 3 pro isokinetic dynamometer. |
| Sel-reported functional status | 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) | Evaluated by Portuguese version of Functional Status Questionnaire (FSQ). |
| Clinical severity of chronic venous insufficiency | 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). | Assessed by Venous Clinical Severity Score. |
Countries
Portugal
Outcome results
None listed