To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each. Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card. Primary outcome measure: a) improvement in venous haemodynamics. Secondary outcome measures: 1. improvement in lower limb oedema 2. improvement in clinical symptoms 3. reduction in lower limb pain and discomfort 4. improvement in quality of life measures 5. device satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
neuromuscular electrical stimulation device
Academic Department of Vascular Surgery, Charing Cross Hospital
London, United Kingdom
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
Time frame: 0 and 6 weeks
Changes in Limb Swelling, Volume
Lower limb oedema measured before and after using the device at 0 and 6 weeks using a perimeter. Limb volume was measured using an optoelectronic limb volumeter. Patients using compression stockings were advised to remove stockings 2 h prior to their appointment. Measurements were taken with the patient seated and the affected leg in a horizontal position. Five readings were taken before and after device usage at Week 0 and Week 6
Time frame: 0 and 6 weeks
Clinical Symptoms
Change in clinical symptoms as assessed by the Venous Clinical Severity Score (VCSS) from 0 to 6 weeks, lower score means improvement. Maximum score on VCSS is 30. Minimum score is 0.
Time frame: 0 and 6 weeks
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