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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

Dates:

Date	Event
26 January 2007	Published

Volume:

Vol.8

Number:

No.7

Number of Pages:

Identifier:

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)

References:

1. Galasko SB: The cost of whiplash-associated disorders. In
Whiplash Injuries: current concepts in prevention diagnosis, and treatment
of the cervical whiplash syndrome Edited by: Gunzburg R, Szpalski M.
Philadelphia: Lippincott-Raven; 1998:283-290.
2. Barnsley L, Lord S, Bogduk N: Whiplash injury: clinical review.
Pain 1994, 58:283-307.
3. Stovner LJ: The nosologic status of the whiplash syndrome: a
critical review based on a methodological approach. Spine
1996, 21:2735-2746.
4. Spitzer WO, Skovron ML, Salmi LR, Cassidy JD, Duranceau J, Suissa
S, Zeiss E: Scientific monograph of the Quebec Task Force on
Whiplash-Associated Disorders: redefining "whiplash" and
its management. Spine 1995, 20(8 Suppl):1S-73S.
5. Verhagen AP, Scholten-Peeters GGM, de Bie RA, Bierma-Zeinstra
SMA: Conservative treatments for whiplash. The Cochrane
Database of Systematic Reviews 2004. Art. No.: CD003338. DOI:
10.1002/14651858.CD003338.pub2.
6. TSO: The Whiplash Book. London: The Stationery Office Ltd;
2002.
7. McClune T, Burton AK, Waddell G: Whiplash associated disorders:
a review of the literature to guide patient information
and advice. Emerg Med J 2002, 19:499-506.
8. Cote P, Cassidy JD, Carroll L, Frank JW, Bombardier C: A systematic
review of the prognosis of acute whiplash and a new conceptual
framework to synthesize the literature. Spine 2001,
26:E445-458.
9. Mayou R, Bryant B: Outcome of 'whiplash' neck injury. Injury
1996, 27:617-23.
10. Hoving JL, Koes BW, de Vet HC, van der Windt DA, Assendelft WJ,
van Mameren H, Deville WL, Pool JJ, Scholten RJ, Bouter LM: Manual
therapy, physical therapy, or continued care by a general
practitioner for patients with neck pain. A randomized, controlled
trial. Ann Intern Med 136:713-22.
11. Evans R, Bronfort G, Nelson B, Goldsmith CH: Two-year Followup
of a randomized clinical trial of spinal manipulation and
two types of exercise for patients with chronic neck pain.
Spine 2002, 27:2383-2389.
12. Kjellman G, Oberg B: A randomized clinical trial comparing
general exercise, McKenzie treatment and a control group
in patients with neck pain. J Rehabil Med 2002, 34:183-190.
13. Sarig-Bahat H: Evidence for exercise therapy in mechanical
neck disorders. Man Ther 2003, 8:10-20.
14. Eldridge SM, Ashy D, Feder GS: Informed patient consent to participation
in cluster randomized trials: an empirical exploration
of trials in primary care. Clinical Trials 2005, 2:91-98.
15. Maitland GD: Peripheral Manipulation 5th edition. Butterworth-Heinemann
.
16. Klaber Moffett J, Torgerson D, Bell-Syer S, Jackson D, Llewlyn-Phillips
H, Farrin A, Barber J: Randomised controlled trial of exercise
for low back pain: clinical outcomes, costs, and preferences.
BMJ 1999, 319:279-83.
17. Rosenfeld M, Gunnarsson R, Borenstein P: Early intervention in
whiplash-associated disorders: a comparison of two treatment
protocols. Spine 2000, 25:1782-7.
18. Donner A, Klar N: Design and analysis of cluster randomization trials in
health research London: Arnold; 2000.
19. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith
G: Sub-group analyses in randomised controlled trial: quantifying
the risks of false-positives and false-negatives. Health
Technol Assess 5(33):.
20. Hunink MGM, Bult JR, deVries J, Weinstein MC: Uncertainty in
decision models analysing cost-effectiveness: the joint distribution
of incremental costs and effectiveness evaluated with
a nonparametric bootstrap method. Medical Decision Making
1998, 18:337-346.
21. Pocock SJ: Clinical trials: A Practical Approach Chichester: Wiley; 1983.
22. Eldridge SM, Ashby D: Statistical Concepts London: Royal College of
General Practitioners; 2000.