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

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Lamb, S. E. (Sallie E.), Gates, Simon, Underwood, M. (Martin) M.D., Cooke, Matthew (Professor of clinical systems design), Ashby, Deborah, Szczepura, Ala, Williams, Mark A., Williamson, Esther M., Withers, Emma J., Isa, Shahrul Mt and Gumber, Anil. (2007) Managing Injuries of the Neck Trial (MINT) : design of a randomised controlled trial of treatments for whiplash associated disorders. BMC Musculoskeletal Disorders, Vol.8 (No.7). ISSN 1471-2474

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Official URL: http://dx.doi.org/10.1186/1471-2474-8-7

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.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Whiplash injuries
Journal or Publication Title:	BMC Musculoskeletal Disorders
Publisher:	Biomed central
ISSN:	1471-2474
Official Date:	26 January 2007
Volume:	Vol.8
Number:	No.7
Number of Pages:	7
Identification Number:	10.1186/1471-2474-8-7
Status:	Peer Reviewed
Access rights to Published version:	Open Access
Description:	Final version (published as open access)
Funder:	NHS R & D HTA Programme (Great Britain) (HTA)
Grant number:	02/35/02 (HTA)
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URI:	http://wrap.warwick.ac.uk/id/eprint/130