Clinical Trial of a Portable Electrical Muscle Stimulator (VeinoPlus®) to Improve Symptoms of Postthrombotic Syndrome.

Limited treatment options exist for postthrombotic syndrome (PTS). We performed a trial in patients with PTS of a portable electrical muscle stimulation device, VeinoPlus®, which delivers electrical impulses to leg muscles for 20 minute periods via 2 cutaneously placed electrode pads. Aims were to determine whether use of the device was a “clinical success” (defined by patient reporting improvement of symptoms, plus an interest and willingness to continue using the device) and improved quality of life (QOL) and severity of PTS findings; and to define optimal electrical intensity for greatest symptom relief.

Patients were told to use different voltages and numbers of treatment periods, and experiment with pad placement, to find intensity, frequency of use, and pad position for optimal PTS symptom relief. Assessments (Villalta score, QOL questionnaire) were obtained at study entry and after 8 weeks of device use.

Twelve patients were enrolled: 3 had severe, 4 moderate, 5 mild PTS. To date, 8 patients have completed the study. Clinical success occurred in 5/8 (63%) of patients. 63% of patients had an improved VEINES questionnaire score on the symptom subscale, 75% on the QOL subscale. Villalta score on the most affected leg improved for 50% of patients. Most patients used the device in the intensity range of 25-35.

The VeinoPlus® electrical stimulation device appears to improve symptoms and QOL for patients with PTS. The study provides the rationale and details needed for a larger follow-up randomized, sham-device controlled, double-blind trial.

No relevant conflicts of interest to declare.