Efficacy of the Stendo Pulsating suit in patients with leg lymphedema: a pilot randomized study.

BACKGROUND

The "shear stress like" effect of pulsating suit sessions at 65 mm Hg (Stendo(®) device), evidenced in healthy volunteers, might stimulate venous return and act as a physiological pump in lymphedema patients.

OBJECTIVES

To evaluate the lower limb total volume (TV) decrease induced by a pulsating suit versus intermittent pneumatic compression (IPC) sessions during a five-day complex decongestive physiotherapy (CDP) treatment.

MATERIALS &

METHODS

Twenty-four leg lymphedema patients were randomized into a CDP group according to the current practices and a CDP group where IPC was replaced by the pulsating suit. Daily care consisted of manual lymphatic drainage (MLD), one hour IPC or Stendo sessions, and bandaging. The Stendo inflatable suit generates heart rate synchronized compression/decompression applied to the lower part of the body. The IPC device was TP05/TP07 (Eureduc Company). Efficacy was assessed by leg TV changes after 5 days' CDP treatment.

RESULTS

TV decreases were more pronounced in the Stendo than the IPC group when adjusted to the baseline TV; TV decrease was 14.2 L (11.2%) in the Stendo group, 11.0 L (8.8%) in the IPC group (p = 0.052 - %TV change p = 0.08). A trend in improved quality of life was reported in favor of the Stendo group over the IPC groups (14.2% [SD: 23.4%] and 6.7% [SD:31.5%], respectively). No adverse event related to the Stendo device was reported.

CONCLUSION

The promising Stendo results open the way to larger clinical studies targeting CDP maintenance and moderate lymphedema in outpatient settings.