Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial (MLDCVI)
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Manual Lymphatic Drainage
Education
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Venous Insufficiency focused on measuring Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage
Eligibility Criteria
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.
Sites / Locations
- Escola Superior de Saúde Dr. Lopes Dias
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual Lymphatic Drainage
Control
Arm Description
One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.
One educational session in group.
Outcomes
Primary Outcome Measures
Quality of Life
Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).
Secondary Outcome Measures
Leg edema
Assessed by leg perimeter.
Lower extremity symptoms
With Visual Analogue Scale was assessed: pain, fatigue, heaviness, itching, sKin irritation, cramps and other.
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.
Clinical severity of chronic venous insufficiency
Assessed by Venous Clinical Severity Score.
Calf muscle strength and ankle range of motion
Evaluated by Biodex system 3 pro isokinetic dynamometer.
Sel-reported functional status
Evaluated by Portuguese version of Functional Status Questionnaire (FSQ).
Full Information
NCT ID
NCT01899482
First Posted
July 10, 2013
Last Updated
March 23, 2016
Sponsor
Technical University of Lisbon
Collaborators
Fundação para a Ciência e a Tecnologia, Escola Superior de Saúde Dr. Lopes Dias, Portugal
1. Study Identification
Unique Protocol Identification Number
NCT01899482
Brief Title
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
Acronym
MLDCVI
Official Title
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Lisbon
Collaborators
Fundação para a Ciência e a Tecnologia, Escola Superior de Saúde Dr. Lopes Dias, Portugal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
Venous Insufficiency, Physical Therapy Techniques, Manual Lymphatic Drainage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Lymphatic Drainage
Arm Type
Experimental
Arm Description
One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
One educational session in group.
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Behavioral education.
Primary Outcome Measure Information:
Title
Quality of Life
Description
Evaluated by portuguese version of Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-2).
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)
Secondary Outcome Measure Information:
Title
Leg edema
Description
Assessed by leg perimeter.
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).
Title
Lower extremity symptoms
Description
With Visual Analogue Scale was assessed: pain, fatigue, heaviness, itching, sKin irritation, cramps and other.
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).
Title
Hemodynamic evidence of severity of chronic venous disease
Description
Venous reflux and anterograde flow during manual leg compression, by duplex ultrasound in femoral vein, great saphenous vein, popliteal vein and small saphenous vein.
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).
Title
Clinical severity of chronic venous insufficiency
Description
Assessed by Venous Clinical Severity Score.
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).
Title
Calf muscle strength and ankle range of motion
Description
Evaluated by Biodex system 3 pro isokinetic dynamometer.
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)
Title
Sel-reported functional status
Description
Evaluated by Portuguese version of Functional Status Questionnaire (FSQ).
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo AS Armada-da-Silva, PhD
Organizational Affiliation
Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, parmada@fmh.utl.pt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior de Saúde Dr. Lopes Dias
City
Castelo Branco
ZIP/Postal Code
6000-270
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.archives-pmr.org/article/S0003-9993(14)01127-7/abstract
Learn more about this trial
Manual Lymphatic Drainage in Chronic Venous Insufficiency: a Randomized Controlled Trial
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