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

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 Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Other: Manual Lymphatic Drainage; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Castelo Branco, Portugal, 6000-270
    • Escola Superior de Saúde Dr. Lopes Dias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Technical University of Lisbon
• Collaborators: Fundação para a Ciência e a Tecnologia; Escola Superior de Saúde Dr. Lopes Dias, Portugal
• Investigators: Principal Investigator: Paulo AS Armada-da-Silva, PhD, Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Venous Insufficiency; Physical Therapy Techniques; Manual Lymphatic Drainage
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: SFRH/BD/62673/2009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: http://www.archives-pmr.org/article/S0003-9993(14)01127-7/abstract