Effectiveness of fluoroscopy-guided manual lymph drainage (MLD) versus traditional MLD or placebo MLD for the treatment of breast cancer-related lymphoedema (BCRL): a randomised controlled trial

Currently, each breast cancer patient with arm lymphedema receives manual lymph drainage (MLD) to treat the edema. Despite this worldwide application of MLD, different systematic reviews conclude that there is no evidence about the effectiveness of lymph drainage to treat BCRL. Belgrado and Tan et al. developed a new and more efficient method of lymph drainage to improve lymph transport, i.e. fluoroscopy-guided MLD. Belgrado has recently shown that MLD with high pressure (vs low pressure) is more effective to improve lymph transport, as well as gliding (vs no gliding). In this study, they only investigated the physiological effect (i.e. change of lymphatic transport) in one session of fluoroscopy-guided MLD. Whether the application of different sessions of fluoroscopy-guided MLD as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, is clinically effective has never been examined. Therefore, a randomised controlled trial will investigate the effect of fluoroscopy-guided MLD versus traditional MLD vs placebo MLD on clinical parameters: namely the lymph transport, the elasticity of the skin, the thickness and reflectivity of the cutis and subcutis investigated with the ultrasonography and the water content in the skin measured with the MoistureMeterD , BIS (Bodystat and Impedimed) and pitting test. A second aim is to assess clinometric parameters (reliability  and responsiveness) of the pitting test, whereby a third aim will be to assess these clinometric parameters (reliability and validity) of the MoistureMeterD to assess the water content in the skin. The fourth aim is to make a comparison concerning the reliability and effectiveness of two different devices concerning BIS: namely the Bodystat and the more expensive Impedimed to examine the extracellular fluid. A fifth and last aim will be a comparison to detect sensitivity concerning three different measurement methods to determine the water content in the skin; pitting test, MoistureMeterD and the BIS.