Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial.
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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.
SUBMITTER: Torres Lacomba M
PROVIDER: S-EPMC2806631 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPodoconiosis (also known as endemic, non-filarial elephantiasis) affects about 4 million subsistence farmers in tropical Africa. Poor awareness of the condition and inadequate evidence for the efficacy of treatment mean that no government in an endemic country yet offers lymphoedema management for patients with podoconiosis. Among patients with filarial lymphoedema, trials suggest that limb care is effective in reducing the most disabling sequelae: episodes of acute dermatolymphangioadenitis. We aimed to test the hypothesis that a simple, inexpensive lymphoedema management package would reduce the incidence of acute dermatolymphangioadenitis in adult patients with podoconiosis in northern Ethiopia.MethodsWe did a pragmatic randomised controlled trial at health posts and health centres in 18 sub-districts of Aneded woreda (district) in Amhara, northern Ethiopia. Participants were adults aged 18 years and older, had a diagnosis of at least stage 2 podoconiosis (persistent lymphoedema) and a negative antigen test for filariasis, and intended to remain within Aneded woreda for the duration of the trial. Patients were randomly assigned (1:1) to either receive a package containing instructions for foot hygiene, skin care, bandaging, exercises, and use of socks and shoes, with support by lay Community Podoconiosis Agents at monthly meetings (intervention group) or to receive no intervention (control group). Participants were aware of their group assignment, but researchers doing all analyses were masked to treatment group. The primary outcome was incidence of acute dermatolymphangioadenitis episodes in the total period of observation of each participant, measured by use of validated patient self-reported pictorial diaries. This trial was registered with the International Standard Randomised Controlled Trials Number Register, number ISRCTN67805210.FindingsBetween Dec 1, 2014, and June 30, 2015, 1339 patients were screened, and 696 patients were enrolled and randomly allocated to treatment groups. We allocated 350 patients to the intervention group and 346 patients to the control group. 321 (92%) patients from the intervention group and 329 (95%) patients from the control group provided follow-up results at 12 months. During the 12 months of follow-up, 16 550 new episodes of acute dermatolymphangioadenitis occurred during 765·2 person-years. The incidence of acute dermatolymphangioadenitis was 19·4 episodes per person-year (95% CI 18·9-19·9) in the intervention group and 23·9 episodes per person-year (23·4-24·4) in the control group. The ratio of incidence rate in the intervention group to that of the control group was 0·81 (0·74 to 0·89; p<0·0001), with a rate difference of -4·5 (-5·1 to -3·8) episodes per person-year. No serious adverse events related to the intervention were reported.InterpretationA simple, inexpensive package of lymphoedema self-care is effective in reducing the frequency and duration of acute dermatolymphangioadenitis. We recommend its implementation by the governments of endemic countries.FundingJoint Global Health Trials scheme (from the Wellcome Trust, the UK Medical Research Council, and UK Aid).
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Project description:BackgroundInnovation in the training of future physiotherapy professionals through the use of collaborative learning could be an effective method for developing advanced competencies such as professional ethics. This study aimed at comparing the effects of cooperative learning and individual learning on the knowledge of professional ethics, the perception of knowledge regarding professional ethics, the teaching quality assessment and satisfaction in future physiotherapy professionals.MethodsA prospective, assessor-blinded, controlled trial was performed. A 12-week program was carried out with future physiotherapy professionals. The cooperative learning group was based on group activities, while the individual learning group performed the same activities with an individual approach. Knowledge, perception of knowledge regarding professional ethics, teaching quality and satisfaction were assessed.ResultsA total of 216 participants completed the study (cooperative group n = 106; individual group n = 110). The cooperative learning group showed higher knowledge and perception of knowledge regarding professional ethics compared to the individual learning group (p < 0.001 and p < 0.001, respectively). Additionally, the cooperative learning group reported higher scores in the teaching materials, attitude towards future professionals and the teacher's global score.ConclusionsCooperative learning showed a positive impact on developing advanced competencies such as knowledge and perception of knowledge regarding professional ethics. Both methodologies showed adequate results in the assessment of teaching quality and satisfaction.
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