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Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial

BACKGROUND: Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ‘Complete Decongestive Therapy’ (CDT). CDT consists of the following components; skin care, manual lymphatic drainage, bandaging and exercises. The scientific evidence regarding what type...

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Autores principales: Tambour, Mette, Tange, Berit, Christensen, Robin, Gram, Bibi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978135/
https://www.ncbi.nlm.nih.gov/pubmed/24708851
http://dx.doi.org/10.1186/1471-2407-14-239
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author Tambour, Mette
Tange, Berit
Christensen, Robin
Gram, Bibi
author_facet Tambour, Mette
Tange, Berit
Christensen, Robin
Gram, Bibi
author_sort Tambour, Mette
collection PubMed
description BACKGROUND: Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ‘Complete Decongestive Therapy’ (CDT). CDT consists of the following components; skin care, manual lymphatic drainage, bandaging and exercises. The scientific evidence regarding what type of treatment is most effective is sparse. The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer. METHODS/DESIGN: A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with arm lymphedema will be recruited from 3 hospitals and randomized into one of two treatment groups A: Complete Decongestive Therapy including manual drainage or B: Complete Decongestive Therapy without manual lymphatic drainage. The intervention period will be approximately 4 weeks followed by a 6 month follow-up period (7 months from baseline). Primary outcome variable: the percentage volume reduction of lymphedema (%) from baseline to 7 months. Secondary outcome variables: Differences from baseline to week 4 and from week 4 to month 7 in circumference of the arm (cm), body weight (kg), patient sensation of heaviness (scale range: 0–10), patient sensation of tension (scale range: 0–10), and quality of life (EQ-5D-5 L-questionnaire). All measurements are standardized and will be performed before randomization, after 4 weeks and after 7 months. DISCUSSION: This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience. TRIAL REGISTRATION: ClinicalTrials.gov: Identifier NCT02015897
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spelling pubmed-39781352014-04-09 Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial Tambour, Mette Tange, Berit Christensen, Robin Gram, Bibi BMC Cancer Study Protocol BACKGROUND: Physical therapy treatment of patients with lymphedema includes treatment based on the principles of ‘Complete Decongestive Therapy’ (CDT). CDT consists of the following components; skin care, manual lymphatic drainage, bandaging and exercises. The scientific evidence regarding what type of treatment is most effective is sparse. The objective of this study is to investigate whether CDT is equally effective if it includes manual lymphatic drainage or not in the treatment of arm lymphedema among patients with breast cancer. METHODS/DESIGN: A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with arm lymphedema will be recruited from 3 hospitals and randomized into one of two treatment groups A: Complete Decongestive Therapy including manual drainage or B: Complete Decongestive Therapy without manual lymphatic drainage. The intervention period will be approximately 4 weeks followed by a 6 month follow-up period (7 months from baseline). Primary outcome variable: the percentage volume reduction of lymphedema (%) from baseline to 7 months. Secondary outcome variables: Differences from baseline to week 4 and from week 4 to month 7 in circumference of the arm (cm), body weight (kg), patient sensation of heaviness (scale range: 0–10), patient sensation of tension (scale range: 0–10), and quality of life (EQ-5D-5 L-questionnaire). All measurements are standardized and will be performed before randomization, after 4 weeks and after 7 months. DISCUSSION: This randomized controlled study seeks to provide data on an effective treatment for patients with breast cancer related arm lymphedema and which at the same time causes minimal patient inconvenience. TRIAL REGISTRATION: ClinicalTrials.gov: Identifier NCT02015897 BioMed Central 2014-04-03 /pmc/articles/PMC3978135/ /pubmed/24708851 http://dx.doi.org/10.1186/1471-2407-14-239 Text en Copyright © 2014 Tambour et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Tambour, Mette
Tange, Berit
Christensen, Robin
Gram, Bibi
Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title_full Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title_fullStr Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title_full_unstemmed Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title_short Effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
title_sort effect of physical therapy on breast cancer related lymphedema: protocol for a multicenter, randomized, single-blind, equivalence trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978135/
https://www.ncbi.nlm.nih.gov/pubmed/24708851
http://dx.doi.org/10.1186/1471-2407-14-239
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