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OpenTrials
Completed

NCT Number: NCT01899482

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

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.

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Key information

Conditions

Chronic Venous Insufficiency Cardiovascular Diseases Vascular Diseases Venous Insufficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde Dr. Lopes Dias

Castelo Branco, 6000-270, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual lymphatic drainage

Other

Education

Behavioral

Behavioral education.

Primary outcomes

  1. Quality of Life

    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)

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

Secondary outcomes

  1. Leg edema

    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).

    Assessed by leg perimeter.

  2. Lower extremity symptoms

    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).

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

  3. Hemodynamic evidence of severity of chronic venous disease

    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).

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

  4. Clinical severity of chronic venous insufficiency

    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).

    Assessed by Venous Clinical Severity Score.

  5. Calf muscle strength and ankle range of motion

    Time frame: 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.

  6. Sel-reported functional status

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Technical University of Lisbon

Other

Collaborators

  • Escola Superior de Saúde Dr. Lopes Dias, Portugal
  • Fundação para a Ciência e a Tecnologia

Registry information

Acronym: MLDCVI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2013
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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