Safety Evaluation of a Device for Treatment of Lymphedema of the Upper Extremity.

Abstract

Lymphedema is a chronic condition characterized by dysfunction of the lymphatic system. There is currently no available cure. The standard of care is complete decongestive physiotherapy performed by a lymphedema therapist. However, lymphedema may flare between appointments, making home care important. There are several medical devices available to treat lymphedema at home, but they can be expensive, noisy, and bulky, restricting patient mobility. Thus, there is a demand for other devices that can be utilized at home, between appointments. The overall goal of this research study is to assess the safety of a newly developed vibratory device that may be utilized to supplement lymphedema treatment. Fourteen healthy subjects were recruited and treated with the device, all while measuring pre-treatment and post-treatment upper extremity circumference/induration, vital signs, pain, side effects, and intra-treatment acceleration produced by the device. There were no significant changes in reported pain or vital signs, and side effects were largely mild and transient. We believe that this device is safe for use in healthy subjects, and further studies should assess the efficacy of this device in treating patients with lymphedema.