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

Katherine J Williams, Hayley M Moore, Mary Ellis, Alun H Davies, Katherine J Williams, Hayley M Moore, Mary Ellis, Alun H Davies

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: electrical; neuromuscular; stimulation; venous disease; venous insufficiency.

Conflict of interest statement

The authors report no competing interests.

© 2021 Williams et al.

Figures

Figure 1
Figure 1
CONSORT diagram of VeINS trial (DNA – did not attend follow-up, VV – varicose vein).
Figure 2
Figure 2
Haemodynamic changes in the femoral vein with neuromuscular electrical stimulation, taken at weeks 0 and 6 (*p

References

    1. Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005;15(3):175–184. doi:10.1016/j.annepidem.2004.05.015
    1. White RH. The epidemiology of venous thromboembolism. Circulation. 2003;107(23 Suppl 1):I4–8. doi:10.1161/01.CIR.0000078468.11849.66
    1. Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994;81(2):167–173. doi:10.1002/bjs.1800810204
    1. Maurins U, Hoffmann BH, Losch C, Jockel KH, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system in the general population–results from the Bonn Vein Study, Germany. J Vasc Surg. 2008;48(3):680–687. doi:10.1016/j.jvs.2008.04.029
    1. Williams KJ, Ayekoloye O, Moore HM, Davies AH. The calf muscle pump revisited. J Vasc Surg. 2014;1–6. doi:10.1016/j.jvsv.2013.10.053
    1. Baker SR, Stacey MC, Jopp-McKay AG, Hoskin SE, Thompson PJ. Epidemiology of chronic venous ulcers. Br J Surg. 1991;78(7):864–867. doi:10.1002/bjs.1800780729
    1. Nelson EA, Mani R, Thomas K, Vowden K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. 2011;2:CD001899–CD001899.
    1. Vowden K. The use of intermittent pneumatic compression in venous ulceration. Br J Nurs. 2001;10(8):491–509. doi:10.12968/bjon.2001.10.8.5312
    1. Comerota AJ. Intermittent pneumatic compression: physiologic and clinical basis to improve management of venous leg ulcers. J Vasc Surg. 2011;53(4):1121–1129. doi:10.1016/j.jvs.2010.08.059
    1. Silverstein MD, Heit JA, Mohr DN, Petterson TM, O’Fallon WM, Melton LJ 3rd. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med. 1998;158(6):585–593. doi:10.1001/archinte.158.6.585
    1. Prandoni P, Lensing AW, Cogo A, et al. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996;125(1):1–7. doi:10.7326/0003-4819-125-1-199607010-00001
    1. Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4):756–764. doi:10.1160/TH07-03-0212
    1. Goldhaber SZ, Fanikos J. Prevention of deep vein thrombosis and pulmonary embolism. Circulation. 2004;110(16):e445–e447. doi:10.1161/01.cir.0000145141.70264.c5
    1. Morris JK, Fincham BM. Intermittent pneumatic compression for venous thromboembolism prophylaxis in total knee arthroplasty. Orthopedics. 2012;35(12):e1716–21. doi:10.3928/01477447-20121120-15
    1. Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015;30(5):365–372. doi:10.1177/0268355514531255
    1. Williams KJ, Davies A. The use of a novel neuromuscular electrical stimulation device in peripheral vascular disease. Int J Case Rep Images. 2014;5(11):744–747. doi:10.5348/ijcri-201462-CS-10048
    1. Williams KJ, Ravikumar R, Babber A, Davies AH. Can neuromuscular stimulation relieve the symptoms of chronic venous disease, and improve quality of life? (abstract). BJS. 2015;102(S5):9.
    1. Ravikumar R, Williams KJ, Davies A. Potential clinical applications of electrical muscle stimulation in venous disease (abstract). BJS. 2015;102(S5):45.
    1. Anderson SI, Whatling P, Hudlicka O, Gosling P, Simms M, Brown MD. Chronic transcutaneous electrical stimulation of calf muscles improves functional capacity without inducing systemic inflammation in claudicants. Eur J Vasc Endovasc Surg. 2004;27(2):201–209. doi:10.1016/j.ejvs.2003.10.003
    1. Kaulesar Sukul DM, den Hoed PT, Johannes EJ, van Dolder R, Benda E. Direct and indirect methods for the quantification of leg volume: comparison between water displacement volumetry, the disk model method and the frustum sign model method, using the correlation coefficient and the limits of agreement. J Biomed Eng. 1993;15(6):477–480. doi:10.1016/0141-5425(93)90062-4
    1. Vasquez MA, Munschauer CE. Revised venous clinical severity score: a facile measurement of outcomes in venous disease. Phlebology. 2012;27(Suppl 1):119–129. doi:10.1258/phleb.2012.012S16
    1. Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: review and revision (CESD and CESD-R). In: Maruish M, editor. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Lawrence Erlbaum; 2004:363–377.
    1. Baldwin MJ, Moore HM, Rudarakanchana N, Gohel M, Davies AH. Post-thrombotic syndrome: a clinical review. J Thromb Haemost. 2013;11(5):795–805. doi:10.1111/jth.12180
    1. Tucker AT, Maass A, Bain DS, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010;19(1):e31–7. doi:10.1055/s-0031-1278361
    1. Nicolaides AN, Kakkar VV, Field ES, Renney JT. The origin of deep vein thrombosis: a venographic study. Br J Radiol. 1971;44(525):653–663. doi:10.1259/0007-1285-44-525-653
    1. Delis KT, Husmann M, Kalodiki E, Wolfe JH, Nicolaides AN. In situ hemodynamics of perforating veins in chronic venous insufficiency. J Vasc Surg. 2001;33(4):773–782. doi:10.1067/mva.2001.112707
    1. Kan YM, Delis KT. Hemodynamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg. 2001;136(12):1364–1369. doi:10.1001/archsurg.136.12.1364
    1. Padberg FT Jr, Johnston MV, Sisto SA. Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial. J Vasc Surg. 2004;39(1):79–87. doi:10.1016/j.jvs.2003.09.036
    1. Comerota A. Intermittent pneumatic compression improves healing of venous ulcers. Vascular. 2009;17:S82–S82.

Source: PubMed

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