Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial
Author:
Burgess Laura12, Babber Adarsh12ORCID, Shalhoub Joseph12ORCID, Smith Sasha12, de la Rosa Consuelo N3, Fiorentino Francesca134, Braithwaite Bruce5, Chetter Ian C6, Coulston James7, Gohel Manjit S8, Hinchliffe Robert9ORCID, Stansby Gerard10, Davies Alun H12ORCID, Gohel M S, Pentelow A, Shipley-Cribb P, Elliot R, Nacorda N, Ward R, Read D, Davies A H, Shalhoub J, Lane T, Bolton L, Le-Magowan T V, Burgess L, Jones B, Strevens N, Malagoni A M, Tavares S, Henry A, Connelly C, Smee J, Toledano R, Nunag J, Tarusan L, Yasmin N, Carr C, Metcalfe J, Page B, Williams S, Hill D, Belt G, Rees A, Palmer S, Horton S, Lovelock D, Stansby G, Parr N, Catterson M, Scott E, Wales L, McCaslin J, Clarke M, Kirkup S, Amis D, Robinson A, Phillipson A, Covill S, Wealleans V, Fairbairn E, Chetter I, Harwood A, Long J, Totty J, Mohamed A, Wallace T, Hatfield J, Cai P, Pymer S, Palmer J, Firth A, Roe T, Ibeggazene S, Andrews L, Coulston J, Stewart A, Roberts K, Rewbury J, Mitchell S, Mills H, Vickery L, Adams C, Shakya S, Hadley R, Timewell L, Williams C, Kanapathipillai J, Hutter J, Goodchild F, Greig N, Blackall J, O’Callaghan K, Lucas J, Braithwaite B, Simpson R, Hadley R, Rittoo D, Thomson C, Vamplew L, Letts M, Webb T, Howe E, Fraine A, Kelly J, Beecham F, Pal N, Hulse M, Patel P, Nordon I, Smith S, Smith F, Yates H, Boxall C, Harvey J, Hammond S, Hinchliffe R, Cheshire H, Harding K, McIntosh S, Poole L, Brock P, Holt P, Sachsinger N, Ingham R, Budge J, Pang J, Ribeiro P,
Affiliation:
1. Department of Surgery and Cancer, Imperial College London , London , UK 2. Imperial Vascular Unit, Imperial College Healthcare NHS Trust , London , UK 3. Imperial Clinical Trials Unit, Imperial College London , London , UK 4. Nightingale-Saunders Clinical Trials & Epidemiology Unit (King’s Clinical Trials Unit), King’s College London , London , UK 5. One Stop Vascular Clinic, Queen’s Medical Centre, Nottingham University Hospitals NHS Trust , Nottingham , UK 6. Academic Vascular Surgical Unit, Hull York Medical School, University of Hull/Hull University Teaching Hospital NHS Trust , Hull , UK 7. Department of Vascular Surgery, Somerset NHS Foundation Trust , Taunton , UK 8. Department of Vascular Surgery, Cambridge University Hospitals NHS Foundation Trust, & NIHR Cambridge Biomedical Research Centre , Cambridge , UK 9. Department of Vascular Surgery, North Bristol NHS Trust , Bristol , UK 10. Northern Vascular Unit, The Newcastle Upon Tyne Hospitals NHS Foundation Trust , Newcastle , UK
Abstract
Abstract
Methods
This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes.
Results
Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported.
Conclusion
Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.
This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.
Funder
Efficacy and Mechanism Evaluation Medical Research Council National Institute for Health and Care Research Neuromuscular electrical stimulation Actegy Ltd laser Doppler flowmetry Moor Instruments Ltd
Publisher
Oxford University Press (OUP)
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