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Open Access Study protocol

Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

Sarah E Lamb12*, Simon Gates1, Martin R Underwood3, Matthew W Cooke1, Deborah Ashby4, Ala Szczepura5, Mark A Williams1, Esther M Williamson1, Emma J Withers1, Shahrul Mt Isa4, Anil Gumber5 and the MINT Study Team

Author Affiliations

1 Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

2 Kadoorie Critical Care Research Centre, John Radcliffe Hospital, Oxford, OX3 9DU, UK

3 Centre for Health Sciences, Abernethy Building, 2 Newark Street, Barts and The London, Whitechapel, London E1 2AT, UK

4 Wolfson Institute of Preventive Medicine, Barts and The London, Queen Mary's School of Medicine & Dentistry, University of London, Charterhouse Square, London EC1M 6BQ, UK

5 Centre for Evidence in Ethnicity, Health and Diversity, Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK

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BMC Musculoskeletal Disorders 2007, 8:7  doi:10.1186/1471-2474-8-7

Published: 26 January 2007

Abstract

Background

A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks.

Methods

Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out.

Conclusion

This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.