Breast Cancer Lymphedema Clinical Trial
Official title:
Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week
treatment with KT than with CG.
Research design:
Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two
groups . The initial sample was selected among the patients of "Breast Pathology
Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.
Cross Design: it made possible to evaluate two different treatments in the same patient,
cancelling intragroup variability.
Open design: it was impossible to blind patients and physiotherapist researcher because of
patent visual differences between the two therapies, CG or KT, both during application and
while being worn, and even in the hours after its removal, due to the marks left on the skin.
However, at least one external evaluator suitably trained was implemented and performed the
randomisation of the groups and collected all patient data. Statistical study was also made
by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de
Octubre) with coded variables to blind the analyst.
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