Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial ´a ´a ´ ´ Marı Torres Lacomba, professor of physiotherapy,1 Marı Jose Yuste Sanchez, professor of physiotherapy,1 ´ ˜ Alvaro Zapico Goni, professor of obstetrics and gynaecology,1,2 David Prieto Merino, lecturer,3 Orlando ´ Mayoral del Moral, professor of physiotherapy,4 Ester Cerezo Tellez, research fellow,1 Elena Minayo ´ Mogollon, research fellow1 1 Physiotherapy Department, School of Physiotherapy, Alcalá de Henares University, E-28871 Alcalá de Henares, Madrid, Spain 2 Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid 3 Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London 4 Physiotherapy Department, Provincial Hospital, Toledo, Spain Correspondence to: M Torres Lacomba firstname.lastname@example.org
Cite this as: BMJ 2010;340:b5396 doi:10.1136/bmj.b5396
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. INTRODUCTION Acquired interruption or damage to the axillary lymphatic system after surgery or radiotherapy for breast
cancer can lead to regional or generalised accumulation of lymph fluid in the interstitial space, known as secondary lymphoedema.1 This condition is the most important chronic complication after dissection of the axillary lymph nodes2-5 and has a tendency to progress. Secondary lymphoedema can cause disfigurement, physical discomfort, and functional impairment. Anxiety, depression, and emotional distress are more common in patients with than without secondary lymphoedema. This can affect social relationships, undermining body image and self esteem.6-8 The condition may also precipitate cellulitis, erysipelas, lymphangitis, and occasionally lymphangiosarcoma.9-11 Reported incidence rates for secondary lymphoedema vary depending on the method used for measurement.12 Inconsistent definitions and the lack of a standard classification system have resulted in diverse incidence rates for secondary lymphoedema, ranging from 5% to 56% within two years after surgery.7 13-16 After axillary lymph node dissection the incidence of secondary lymphoedema is about 23-38% if the criterion used to identify it is a greater than 2 cm increase in upper arm...
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