Clinical evaluation of a device to treat upper extremity lymphedema

<h2>Abstract</h2><h3>Objective</h3> The LymphaVibe is a newly developed medical device that uses vibration to treat upper extremity lymphedema. Previous studies have demonstrated that the device is safe to use in healthy participants. This study aims to assess the preliminary efficacy and safety of this device when used in patients with clinical upper extremity lymphedema. <h3>Methods</h3> This prospective cohort study enrolled 15 patients who were receiving lymphedema therapy through our institution's outpatient program. Participants received treatment with the LymphaVibe before their standard of care therapy and were seen once a week for 4 weeks. End points included upper extremity circumference, upper extremity induration, lymphedema-related patient reported outcomes (Lymphedema Life Impact Scale), and safety. <h3>Results</h3> Treatment with the LymphaVibe resulted in a significant decrease in upper extremity circumference at 30 cm (<i>P</i> = .012; d=0.34) and 40 cm (<i>P</i> = .011; d=0.34) above the wrist. This correlated with a significant increase in induration at 30 cm (<i>P</i> = .017; d=−0.32). Treatment with the LymphaVibe was associated with a significant decrease in total Lymphedema Life Impact Score (<i>P</i> < .01; d=0.70), as well as significant decreases in all subcategories, except upper extremity strength. Out of 60 total visits, a side effect was reported in 2 and an unexpected problem was reported in 2. There were no adverse events, and no patient elected to terminate a study visit or unenroll owing to discomfort with device use. <h3>Conclusions</h3> The LymphaVibe is safe to use in patients with a diagnosis of upper extremity lymphedema. Although limited by the small sample size, the preliminary efficacy results are promising and warrant further investigation.