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

Chronic Venous Insufficiency Clinical Trial

— MLDCVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899482
• Other study ID #: SFRH/BD/62673/2009
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: March 23, 2016
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Technical University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Faculdade de Motricidade Humana, Universidade Técnica de Lisboa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Other:
• Manual Lymphatic Drainage

Behavioral:
• Education
Behavioral education.

Locations

Country	Name	City	State
Portugal	Escola Superior de Saúde Dr. Lopes Dias	Castelo Branco

Sponsors (3)

Lead Sponsor	Collaborator
Technical University of Lisbon	Escola Superior de Saúde Dr. Lopes Dias, Portugal, Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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)	No
Secondary	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)	No