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Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the long term: a randomised trial [with consumer summary]
Devoogdt N, Geraerts I, van Kampen M, de Vrieze T, Vos L, Neven P, Vergote I, Christiaens MR, Thomis S, de Groef A
Journal of Physiotherapy 2018 Oct;64(4):245-254
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

QUESTION: What are the short-term and long-term preventive effects of manual lymph drainage (MLD), when used in addition to information and exercise therapy, on the development of lymphoedema after axillary dissection for breast cancer? DESIGN: Randomised controlled trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Adults undergoing unilateral dissection for breast cancer were recruited, with 79 allocated to the experimental group and 81 to the control group. INTERVENTION: The experimental group received guidelines about prevention of lymphoedema, exercise therapy and MLD. The control group received the same guidelines and exercise therapy, but no MLD. The interventions in both groups were delivered for 6 months. OUTCOME MEASURES: The primary outcome was cumulative incidence of arm lymphoedema defined in four ways (>= 200 ml, >= 2 cm, >= 5%, and >= 10% increase), which represent the difference in arm volume or circumference between the affected and healthy sides compared with the difference before surgery. Secondary outcomes included point prevalence of lymphoedema, change in arm volume difference, shoulder range of movement, quality of life and function. RESULTS: Incidence rates were comparable between experimental and control groups at all follow-up measurements. Sixty months after surgery, the cumulative incidence rate for the > = 200 ml definition was 35% for the experimental group versus 29% for the control group (RR 0.89, 95% CI 0.51 to 1.54, p = 0.45); for the >=2 cm definition 35% versus 38% (RR 0.93, 95% CI 0.59 to 1.45, p = 0.73); for the > = 5% definition 68% versus 53% (RR 1.28, 95% CI 0.97 to 1.69, p = 0.08) and for the >= 10% definition 28% versus 24% (RR 1.18, 95% CI 0.66 to 2.10, p = 0.57). The secondary outcomes were comparable between the groups at most assessment points. CONCLUSION: Manual lymph drainage may not have a preventive effect on the development of breast cancer-related lymphoedema in the short and long term. TRIAL REGISTRATION: Netherlands Trial Register NTR 1055.

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