A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]
Identifieur interne : 001B07 ( Pmc/Curation ); précédent : 001B06; suivant : 001B08A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]
Auteurs : Olivia Wilburn [États-Unis] ; Paul Wilburn [États-Unis] ; Stanley G. Rockson [États-Unis]Source :
- BMC Cancer [ 1471-2407 ] ; 2006.
Abstract
Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT), including manual lymphatic drainage (MLD), have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch™, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch™, when compared to massage, in the self-administered maintenance therapy of lymphedema.
A prospective, randomized, crossover study of maintenance therapy was performed in 10 patients with unilateral breast cancer-associated lymphedema of the arm. Each observation phase included self-administered treatment with the Flexitouch™ or massage, 1 hour daily for 14 days, respectively, followed by crossover to the alternate treatment phase. Each treatment phase was preceded by a 1 week treatment washout, with use of garment only. The sequence of treatment was randomly assigned. The potential impact of treatment modality on quality of life was assessed with serial administration of the SF-36.
Statistical analysis disclosed that the order of treatment had no outcome influence, permitting 10 comparisons within each treatment group. Post-treatment arm volume reduced significantly after the Flexitouch™, but not after self-administered massage. The patients' mean weight decreased significantly with Flexitouch™ use, but not with massage. The Flexitouch™ device was apparently well-tolerated and accepted by patients. Serial SF-36 administration showed no deterioration in physical or psychosocial scores compared to baseline measurements; there were no statistical differences in scores when the two treatment modalities were compared.
This short-term prospective evaluation of the Flexitouch™ suggests that the device may provide better maintenance edema control than self-adiminstered massage in breast cancer-associated lymphedema. The apparent ease of use and reliability of response to the device suggest that further broad-scale testing is warranted.
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DOI: 10.1186/1471-2407-6-84
PubMed: 16571129
PubMed Central: 1440867
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Rockson</name><affiliation wicri:level="1"><nlm:aff id="I1">Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">16571129</idno><idno type="pmc">1440867</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1440867</idno><idno type="RBID">PMC:1440867</idno><idno type="doi">10.1186/1471-2407-6-84</idno><date when="2006">2006</date><idno type="wicri:Area/Pmc/Corpus">001B08</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001B08</idno><idno type="wicri:Area/Pmc/Curation">001B07</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001B07</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]</title><author><name sortKey="Wilburn, Olivia" sort="Wilburn, Olivia" uniqKey="Wilburn O" first="Olivia" last="Wilburn">Olivia Wilburn</name><affiliation wicri:level="1"><nlm:aff id="I1">Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305</wicri:regionArea></affiliation></author><author><name sortKey="Wilburn, Paul" sort="Wilburn, Paul" uniqKey="Wilburn P" first="Paul" last="Wilburn">Paul Wilburn</name><affiliation wicri:level="1"><nlm:aff id="I1">Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305</wicri:regionArea></affiliation></author><author><name sortKey="Rockson, Stanley G" sort="Rockson, Stanley G" uniqKey="Rockson S" first="Stanley G" last="Rockson">Stanley G. Rockson</name><affiliation wicri:level="1"><nlm:aff id="I1">Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305, USA</nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305</wicri:regionArea></affiliation></author></analytic><series><title level="j">BMC Cancer</title><idno type="eISSN">1471-2407</idno><imprint><date when="2006">2006</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT), including manual lymphatic drainage (MLD), have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch™, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch™, when compared to massage, in the self-administered maintenance therapy of lymphedema.</p></sec><sec sec-type="methods"><title>Methods</title><p>A prospective, randomized, crossover study of maintenance therapy was performed in 10 patients with unilateral breast cancer-associated lymphedema of the arm. Each observation phase included self-administered treatment with the Flexitouch™ or massage, 1 hour daily for 14 days, respectively, followed by crossover to the alternate treatment phase. Each treatment phase was preceded by a 1 week treatment washout, with use of garment only. The sequence of treatment was randomly assigned. The potential impact of treatment modality on quality of life was assessed with serial administration of the SF-36.</p></sec><sec><title>Results</title><p>Statistical analysis disclosed that the order of treatment had no outcome influence, permitting 10 comparisons within each treatment group. Post-treatment arm volume reduced significantly after the Flexitouch™, but not after self-administered massage. The patients' mean weight decreased significantly with Flexitouch™ use, but not with massage. The Flexitouch™ device was apparently well-tolerated and accepted by patients. Serial SF-36 administration showed no deterioration in physical or psychosocial scores compared to baseline measurements; there were no statistical differences in scores when the two treatment modalities were compared.</p></sec><sec><title>Conclusion</title><p>This short-term prospective evaluation of the Flexitouch™ suggests that the device may provide better maintenance edema control than self-adiminstered massage in breast cancer-associated lymphedema. The apparent ease of use and reliability of response to the device suggest that further broad-scale testing is warranted.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Cancer</journal-id><journal-title>BMC Cancer</journal-title><issn pub-type="epub">1471-2407</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">16571129</article-id><article-id pub-id-type="pmc">1440867</article-id><article-id pub-id-type="publisher-id">1471-2407-6-84</article-id><article-id pub-id-type="doi">10.1186/1471-2407-6-84</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]</article-title></title-group><contrib-group><contrib id="A1" contrib-type="author"><name><surname>Wilburn</surname><given-names>Olivia</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>owilburn@gmail.com</email></contrib><contrib id="A2" contrib-type="author"><name><surname>Wilburn</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>willnotburn@gmail.com</email></contrib><contrib id="A3" corresp="yes" contrib-type="author"><name><surname>Rockson</surname><given-names>Stanley G</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>srockson@cvmed.stanford.edu</email></contrib></contrib-group><aff id="I1"><label>1</label>Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Falk Cardiovascular Research Center, Stanford, California 94305, USA</aff><pub-date pub-type="collection"><year>2006</year></pub-date><pub-date pub-type="epub"><day>29</day><month>3</month><year>2006</year></pub-date><volume>6</volume><fpage>84</fpage><lpage>84</lpage><ext-link ext-link-type="uri" xlink:href="http://www.biomedcentral.com/1471-2407/6/84"></ext-link><history><date date-type="received"><day>4</day><month>11</month><year>2005</year></date><date date-type="accepted"><day>29</day><month>3</month><year>2006</year></date></history><copyright-statement>Copyright © 2006 Wilburn et al; licensee BioMed Central Ltd.</copyright-statement><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/2.0"><p>This is an Open Access article distributed under the terms of the Creative Commons Attribution License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/2.0"></ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</p></license><abstract><sec><title>Background</title><p>Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT), including manual lymphatic drainage (MLD), have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch™, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch™, when compared to massage, in the self-administered maintenance therapy of lymphedema.</p></sec><sec sec-type="methods"><title>Methods</title><p>A prospective, randomized, crossover study of maintenance therapy was performed in 10 patients with unilateral breast cancer-associated lymphedema of the arm. Each observation phase included self-administered treatment with the Flexitouch™ or massage, 1 hour daily for 14 days, respectively, followed by crossover to the alternate treatment phase. Each treatment phase was preceded by a 1 week treatment washout, with use of garment only. The sequence of treatment was randomly assigned. The potential impact of treatment modality on quality of life was assessed with serial administration of the SF-36.</p></sec><sec><title>Results</title><p>Statistical analysis disclosed that the order of treatment had no outcome influence, permitting 10 comparisons within each treatment group. Post-treatment arm volume reduced significantly after the Flexitouch™, but not after self-administered massage. The patients' mean weight decreased significantly with Flexitouch™ use, but not with massage. The Flexitouch™ device was apparently well-tolerated and accepted by patients. Serial SF-36 administration showed no deterioration in physical or psychosocial scores compared to baseline measurements; there were no statistical differences in scores when the two treatment modalities were compared.</p></sec><sec><title>Conclusion</title><p>This short-term prospective evaluation of the Flexitouch™ suggests that the device may provide better maintenance edema control than self-adiminstered massage in breast cancer-associated lymphedema. The apparent ease of use and reliability of response to the device suggest that further broad-scale testing is warranted.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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