Arm Lymphedema After Breast Cancer Clinical Trial
Official title:
Effectiveness of the Combination of Compression Bandaging and Manual Lymph Drainage in Women With Secondary Lymphedema After Breast Cancer.
Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.
This study has two sub research: a quantitative approach and a qualitative approach. The
research will be carried out by a multicenter way
Quantitative approach consist in carried out a single-blind randomized controlled trial of
44 women with arm lymphedema. Patients will be distributed in two intervention groups by a
randomized way. Participants will be given his assignment by closed envelope. Both
treatments will be administered five days a week for six weeks. The experimental group
(n=22) will receive multimodal treatment: combination of manual lymphatic drainage and
compression bandaging. The control group (n=22) only will receive manual lymphatic drainage.
We want to determinate the effect on volume arm decrease, quality of life, level of hand
strength, degree of pain, fatigue level, and state of anxiety and depression. The influence
on the lymphedema will be analyzed with lower limbs strength, physical activity, lung
function, respiratory muscle strength by maximal inspiratory and expiratory pressure
measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence
will be analyzed by a smartphone.
Qualitative apprach: to know the perceptions and experiences of the participants in both
interventions groups through a qualitative descriptive study. Data will be obtained with
semi-structured depth interview.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment