This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
Time frame: 0 and 6 weeks
Venous Flow Parameters - PV
Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Time frame: 0 and 6 weeks
Venous Flow Parameters - VF
Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Time frame: 0 and 6 weeks
Microcirculatory Blood Flow
Microcirculatory blood flow measure utilising flux arbitrary units.
Time frame: 0 and 6 weeks.
Limb Volume
Change in limb volume assessed in ml.
Time frame: 0 and 6 weeks
Venous Clinical Severity
Clinical severity of venous disease as measured by the venous clinical severity score (VCSS). Scale measure from 0-30, with higher values indicating worse status. It is made up of 10 variables scored from 0-3
Time frame: 0 and 6 weeks.
Patient Compliance
Compliance with device usage assessed with a patient completed diary.
Time frame: 6 weeks.
Generic Quality of Life - EQ-5D-5L
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead).
Time frame: 0 and 6 weeks
Generic Quality of Life - SF-12
Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
Time frame: 0 and 6 weeks
Generic Quality of Life - EQ-VAS
Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
Time frame: 0 and 6 weeks
Disease Specific Quality of Life
quality of life as assessed on the Aberdeen varicose vein questionnaire scale (0-100). This is a patient reported quality of life measure, which assesses symptoms of varicose veins. Higher values are worse.
Time frame: 0 weeks and 6 weeks