Manual Lymphatic Drainage in the Superior Member in Women in Post-surgery for Breast Cancer

NCT ID: NCT02475174

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-03-31

Brief Summary

Evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer.

Detailed Description

The aim of the study is to evaluate the effect of Manual Lymphatic Drainage (MLD) massage in arterial and venous circulation of the upper limb ipsilateral of women submitted after axillary lymphadenectomy breast cancer. Will be evaluated 30 volunteers aged between 40 and 60 years, divided into 2 equal groups, submitted at MLD: Group 1 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage without upper limb elevation; Group 2 - volunteers who underwent surgery for breast cancer that have lymphedema, subject to manual lymphatic drainage with the upper limb elevation to 30º. Data will be collected by ultrasound Doppler in vein and brachial artery before, after MLD, immediately after, and 30 minutes after therapeutic treatment, with and without elevation of 30°, cross over delimitation, being made a therapy session for therapeutic use with and without elevation, with interval period (washout) for seven days. The order of treatment protocols will be randomized by simple raffle for each volunteer. The data within and between groups will be evaluated by a statistical test t student or ANOVA. Otherwise it will be used Kruskal-Wallis followed test by Dunn. Data processing will be performed by software and fixed the critical level of 5% (p<0,05).

Conditions

Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Without upper limb elevation

Manual lymphatic drainage will be held with the voluntary supine without upper limb elevation.

Group Type: EXPERIMENTAL

Without upper limb elevation

Intervention Type: OTHER

Lymphatic drainage without elevation of the upper limb.

Upper limb elevation to 30º

Manual lymphatic drainage will be held with the voluntary supine with the upper limb elevation to 30º.

Group Type: EXPERIMENTAL

Upper limb elevation to 30º

Intervention Type: OTHER

Lymphatic drainage with elevation of the upper limb to 30º.

Interventions

Without upper limb elevation

Lymphatic drainage without elevation of the upper limb.

Intervention Type: OTHER

Upper limb elevation to 30º

Lymphatic drainage with elevation of the upper limb to 30º.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women with axillary lymphadenectomy surgery
• Lymphedema
• Aged 40-60 years.

Exclusion Criteria

• Women with muscle-tendon injury and / or joint injuries member
• Skin disorders
• circulatory diseases.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Elaine Caldeira de Oliveira Guirro

Lais Mara Siqueira das Neves

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elaine Guirro

Role: CONTACT

ecguirro@fmrp.usp.br

(16)3315-0215

Lais Neves

Role: CONTACT

laisneves@usp.br

(16) 3315-0215

Other Identifiers

HCRP nº 13408/2013

Identifier Type: -

Identifier Source: org_study_id