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

NCT ID: NCT01899482

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Chronic Venous Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Manual Lymphatic Drainage

One educational session in group, and 10 individual sessions of manual lymphatic drainage in lower extremity, during approximately one month.

Group Type EXPERIMENTAL

Manual Lymphatic Drainage

Intervention Type OTHER

Education

Intervention Type BEHAVIORAL

Behavioral education.

Control

One educational session in group.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Behavioral education.

Interventions

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Manual Lymphatic Drainage

Intervention Type OTHER

Education

Behavioral education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

Escola Superior de Saúde Dr. Lopes Dias, Portugal

UNKNOWN

Sponsor Role collaborator

Technical University of Lisbon

OTHER

Sponsor Role lead

Responsible Party

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Rute Sofia dos Santos Crisóstomo

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo AS Armada-da-Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Motricidade Humana, Estrada da Costa, 1499-002 Cruz Quebrada,Portugal, Phone number: +351214149248, [email protected]

Locations

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Escola Superior de Saúde Dr. Lopes Dias

Castelo Branco, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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SFRH/BD/62673/2009

Identifier Type: -

Identifier Source: org_study_id

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