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

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency
• Interventions: Other: Manual Lymphatic Drainage; Behavioral: Education

• Registration Number: NCT01899482
• Lead Sponsor: Technical University of Lisbon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-15
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Lymphatic Drainage	Manual Lymphatic Drainage	One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.
Manual Lymphatic Drainage	Education	One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.
Control	Education	One educational session in group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.
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.
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.
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.

Trial Locations

Locations (1)

Escola Superior de Saúde Dr. Lopes Dias; 🇵🇹 Castelo Branco, Portugal