Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease

Abstract

Introduction

Neuromuscular stimulation (NMES) has been shown to improve peripheral blood flow in healthy people. We investigated the effect of bilateral leg NMES on the symptoms of chronic venous disease.

Methods

Forty subjects were recruited from four groups: healthy, superficial insufficiency, deep insufficiency, and deep obstruction. Haemodynamic venous measurements were taken from the right femoral vein with ultrasound, laser Doppler fluximetry from the left hand and foot. Devices were then worn for 4–6 hours per day, for 6 weeks. Haemodynamic measurements were repeated at week 6. Quality of life questionnaires were taken at week 0, 6 and 8.

Results

The mean age was 48.7, BMI 28.6kg/m2, and maximum calf circumference 39.0 cm. Twenty-four subjects were men. NMES increased femoral vein peak velocity, TAMV and volume flow by 55%, 20%, 36% at 20 minutes (all p<0.05), which was enhanced at week 6 (PV and TAMV p<0.05). Mean increases in arm and leg fluximetry were 71% and 194% (both p<0.01). Leg swelling was reduced by mean 252.7 mL (13%, p<0.05) overall; 338.9 mL (16%, p<0.05) in venous disease. For those with venous pathology, scores for disease specific and generic quality of life questionnaires improved. Those with C4-6 disease benefitted the most, with improvements in VDS score of 1, AVVQ of 6, and SF-12 of 10.

Conclusion

NMES improves venous haemodynamic parameters in chronic venous disease, which is enhanced by regular use. NMES reduces leg oedema, improves blood supply to the skin of the foot, and may positively affect quality of life.

Clinical Trials

This trial was registered with www.clinicaltrials.org.uk (NCT02137499).

Keywords:

• neuromuscular
• electrical
• stimulation
• venous disease
• venous insufficiency

Data Sharing Statement

Anonymised data sharing will be considered according to reasonable request, by contacting the corresponding author directly.

Acknowledgments

This paper forms part of a research thesis of the first author (KJW), submitted to Imperial College London and available in their electronic repository (https://spiral.imperial.ac.uk/). All work presented here are the authors’ own works and have not been published in a journal previously. The abstract of this paper was presented at the American Venous Forum, February 2015, as a poster presentation with interim findings (https://www.veinforum.org/wp-content/uploads/2018/05/AM15FinalProgramV4sm.pdf).

Disclosure

The authors report no competing interests.

Additional information

Funding

This research was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre, based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed are those of the authors and not necessarily those of the NHS, NIHR, or Department of Health. The research was funded by the European Venous Forum, Royal Society of Medicine, the Graham-Dixon Charitable Trust, and the Royal College of Surgeons of England. Ultrasound equipment and NMES devices were supplied through an unrestricted academic grant from Firstkind Ltd. The authors had sole control over analysis, manuscript preparation, and publication of the results.