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Randomized Controlled Trial
. 2010 Jan 12:340:b5396.
doi: 10.1136/bmj.b5396.

Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial

María Torres Lacomba  1 , María José Yuste Sánchez, Alvaro Zapico Goñi, David Prieto Merino, Orlando Mayoral del Moral, Ester Cerezo Téllez, Elena Minayo Mogollón
Affiliations
Randomized Controlled Trial

Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial

María Torres Lacomba et al. BMJ. .

Abstract

Objective: To determine the effectiveness of early physiotherapy in reducing the risk of secondary lymphoedema after surgery for breast cancer.

Design: Randomised, single blinded, clinical trial.

Setting: University hospital in Alcalá de Henares, Madrid, Spain.

Participants: 120 women who had breast surgery involving dissection of axillary lymph nodes between May 2005 and June 2007.

Intervention: The early physiotherapy group was treated by a physiotherapist with a physiotherapy programme including manual lymph drainage, massage of scar tissue, and progressive active and action assisted shoulder exercises. This group also received an educational strategy. The control group received the educational strategy only.

Main outcome measure: Incidence of clinically significant secondary lymphoedema (>2 cm increase in arm circumference measured at two adjacent points compared with the non-affected arm).

Results: 116 women completed the one year follow-up. Of these, 18 developed secondary lymphoedema (16%): 14 in the control group (25%) and four in the intervention group (7%). The difference was significant (P=0.01); risk ratio 0.28 (95% confidence interval 0.10 to 0.79). A survival analysis showed a significant difference, with secondary lymphoedema being diagnosed four times earlier in the control group than in the intervention group (intervention/control, hazard ratio 0.26, 95% confidence interval 0.09 to 0.79).

Conclusion: Early physiotherapy could be an effective intervention in the prevention of secondary lymphoedema in women for at least one year after surgery for breast cancer involving dissection of axillary lymph nodes.

Trial registration: Current controlled trials ISRCTN95870846.

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Conflict of interest statement

Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; and (4) no non-financial interests that may be relevant to the submitted work.

Figures

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Fig 1 Progress of participants through study
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Fig 2 Increase in volume ratios between arms. Vertical lines correspond to cut-off values for diagnoses of lymphoedema in other studies (>5% and >10% increase)
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Fig 3 Maximum increase in arm circumference (affected arm−unaffected arm) that could be observed at least at two adjacent points. Vertical line corresponds to binary criteria used here to diagnose lymphoedema—that is, a 2 cm or greater increase in arm circumference observed at least at two adjacent points in affected arm compared with unaffected arm
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Fig 4 Failure time for development of secondary lymphoedema by group
See this image and copyright information in PMC

Comment in

References

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