Effect of an Enhanced Self-Care Protocol on Lymphedema Status among People Affected by Moderate to Severe Lower-Limb Lymphedema in Bangladesh, a Cluster Randomized Controlled Trial

Background: Lymphatic filariasis (LF) is a major cause of lymphedema, affecting over 16 million people globally. A daily, hygiene-centered self-care protocol is recommended and effective in reducing acute attacks caused by secondary infections. It may also reverse lymphedema status in early stages, but less so as lymphedema advances. Lymphatic stimulating activities such as self-massage and deep-breathing have proven beneficial for cancer-related lymphedema, but have not been tested in LF-settings. Therefore, an enhanced self-care protocol was trialed among people affected by moderate to severe LF-related lymphedema in northern Bangladesh. Methods: Cluster randomization was used to allocate participants to either standard- or enhanced-self-care groups. Lymphedema status was determined by lymphedema stage, mid-calf circumference, and mid-calf tissue compressibility. Results: There were 71 patients in each group and at 24 weeks, both groups had experienced significant improvement in lymphedema status and reduction in acute attacks. There was a significant and clinically relevant between-group difference in mid-calf tissue compressibility with the biggest change observed on legs affected by severe lymphedema in the enhanced self-care group ( increment 21.5%, -0.68 (-0.91, -0.45),p< 0.001). Conclusion: This study offers the first evidence for including lymphatic stimulating activities in recommended self-care for people affected by moderate and severe LF-related lymphedema.