Randomized Controlled Trial

. 2023 Nov 9;110(12):1785-1792.

doi: 10.1093/bjs/znad299.

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial

Laura Burgess^{1

2}, Adarsh Babber^{1

2}, Joseph Shalhoub^{1

2}, Sasha Smith^{1

2}, Consuelo N de la Rosa³, Francesca Fiorentino^{1

3

4}, Bruce Braithwaite⁵, Ian C Chetter⁶, James Coulston⁷, Manjit S Gohel⁸, Robert Hinchliffe⁹, Gerard Stansby¹⁰, Alun H Davies^{1

2}; NESIC Trial Investigators

Collaborators, Affiliations

Collaborators

NESIC Trial Investigators:
M S Gohel, A Pentelow, P Shipley-Cribb, R Elliot, N Nacorda, R Ward, D Read, A H Davies, J Shalhoub, T Lane, L Bolton, T V Le-Magowan, L Burgess, B Jones, N Strevens, A M Malagoni, S Tavares, A Henry, C Connelly, J Smee, R Toledano, J Nunag, L Tarusan, N Yasmin, C Carr, J Metcalfe, B Page, S Williams, D Hill, G Belt, A Rees, S Palmer, S Horton, D Lovelock, G Stansby, N Parr, M Catterson, E Scott, L Wales, J McCaslin, M Clarke, S Kirkup, D Amis, A Robinson, A Phillipson, S Covill, V Wealleans, E Fairbairn, I Chetter, A Harwood, J Long, J Totty, A Mohamed, T Wallace, J Hatfield, P Cai, S Pymer, J Palmer, A Firth, T Roe, S Ibeggazene, L Andrews, J Coulston, A Stewart, K Roberts, J Rewbury, S Mitchell, H Mills, L Vickery, C Adams, S Shakya, R Hadley, L Timewell, C Williams, J Kanapathipillai, J Hutter, F Goodchild, N Greig, J Blackall, K O'Callaghan, J Lucas, B Braithwaite, R Simpson, R Hadley, D Rittoo, C Thomson, L Vamplew, M Letts, T Webb, E Howe, A Fraine, J Kelly, F Beecham, N Pal, M Hulse, P Patel, I Nordon, S Smith, F Smith, H Yates, C Boxall, J Harvey, S Hammond, R Hinchliffe, H Cheshire, K Harding, S McIntosh, L Poole, P Brock, P Holt, N Sachsinger, R Ingham, J Budge, J Pang, P Ribeiro

Affiliations

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.

PMID: 37748866
PMCID: PMC10638544
DOI: 10.1093/bjs/znad299

Randomized Controlled Trial

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial

Laura Burgess et al. Br J Surg. 2023.

. 2023 Nov 9;110(12):1785-1792.

doi: 10.1093/bjs/znad299.

Authors

Collaborators

NESIC Trial Investigators:
M S Gohel, A Pentelow, P Shipley-Cribb, R Elliot, N Nacorda, R Ward, D Read, A H Davies, J Shalhoub, T Lane, L Bolton, T V Le-Magowan, L Burgess, B Jones, N Strevens, A M Malagoni, S Tavares, A Henry, C Connelly, J Smee, R Toledano, J Nunag, L Tarusan, N Yasmin, C Carr, J Metcalfe, B Page, S Williams, D Hill, G Belt, A Rees, S Palmer, S Horton, D Lovelock, G Stansby, N Parr, M Catterson, E Scott, L Wales, J McCaslin, M Clarke, S Kirkup, D Amis, A Robinson, A Phillipson, S Covill, V Wealleans, E Fairbairn, I Chetter, A Harwood, J Long, J Totty, A Mohamed, T Wallace, J Hatfield, P Cai, S Pymer, J Palmer, A Firth, T Roe, S Ibeggazene, L Andrews, J Coulston, A Stewart, K Roberts, J Rewbury, S Mitchell, H Mills, L Vickery, C Adams, S Shakya, R Hadley, L Timewell, C Williams, J Kanapathipillai, J Hutter, F Goodchild, N Greig, J Blackall, K O'Callaghan, J Lucas, B Braithwaite, R Simpson, R Hadley, D Rittoo, C Thomson, L Vamplew, M Letts, T Webb, E Howe, A Fraine, J Kelly, F Beecham, N Pal, M Hulse, P Patel, I Nordon, S Smith, F Smith, H Yates, C Boxall, J Harvey, S Hammond, R Hinchliffe, H Cheshire, K Harding, S McIntosh, L Poole, P Brock, P Holt, N Sachsinger, R Ingham, J Budge, J Pang, P Ribeiro

Affiliations

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.

PMID: 37748866
PMCID: PMC10638544
DOI: 10.1093/bjs/znad299

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.

Plain language summary

Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.

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Figures

**Fig. 1**
Cumulative numbers of patients who had been lost to follow-up and had died by each follow-up time point Ten patients were excluded post-randomization. Patients at SET centres attended their first SET class within 2 weeks from randomization. Treatment protocol violations occurred in 6 patients in the control group (SET and non-SET groups) and in 5 patients in the SET intervention group.

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References

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1. National Health Service (NHS) . Diagnosis. Peripheral arterial disease (PAD).https://www.nhs.uk/conditions/peripheral-arterial-disease-pad/diagnosis/
1. Morcos R, Louka B, Tseng A, Misra S, McBane R, Esser Het al. . The evolving treatment of peripheral arterial disease through guideline-directed recommendations. J Clin Med 2018;7:9. - PMC - PubMed
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1. Spentzouris G, Labropoulos N. The evaluation of lower-extremity ulcers. Semin Intervent Radiol 2009;26:286–295 - PMC - PubMed

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Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial

Collaborators

Affiliations

Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial

Authors

Collaborators

Affiliations

Abstract

Plain language summary

Figures

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References

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MeSH terms

Grants and funding

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Abstract

Plain language summary

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