Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trialBMJ 2010; 340 doi: http://dx.doi.org/10.1136/bmj.b5396 (Published 13 January 2010) Cite this as: BMJ 2010;340:b5396
- María Torres Lacomba, professor of physiotherapy1,
- María José Yuste Sánchez, professor of physiotherapy1,
- Álvaro Zapico Goñi, professor of obstetrics and gynaecology12,
- David Prieto Merino, lecturer3,
- Orlando Mayoral del Moral, professor of physiotherapy4,
- Ester Cerezo Téllez, research fellow1,
- Elena Minayo Mogollón, research fellow1
- 1Physiotherapy Department, School of Physiotherapy, Alcalá de Henares University, E-28871 Alcalá de Henares, Madrid, Spain
- 2Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid
- 3Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London
- 4Physiotherapy Department, Provincial Hospital, Toledo, Spain
- Correspondence to: M Torres Lacomba
- Accepted 9 October 2009
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.
We thank the staff and patients of the Gynecology Service of Príncipe de Asturias University Hospital (Madrid), the Physical Therapy Research Unit at Alcala University (Madrid), and Jean Claude Ferrandez for their valuable suggestions. The Physical Therapy Department of Alcalá University and Principe de Asturias Hospital provided the facilities for the study.
Contributors: MTL conceived and designed the study. AZG recruited the patients. MTL (blinded assessor), ECT, EMM (physiotherapy and educational strategies in the early physiotherapy group), and MJYS (educational strategies in control group) devised the interventions. DPM (blinded analyst), MTL, and OMdM analysed and interpreted the data. OMdM collected and assembled the data. MTL, OMdM, and DPM wrote the manuscript. All authors approved the final manuscript.
Funding: This study was funded by the Health Institute Carlos III (Protocol PI071124) of the Spanish Health Ministry.
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.
Ethical approval: This study was approved by the human research ethics committee of the Príncipe de Asturias Hospital.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.