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ISRCTN
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ISRCTN33302125
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DOI
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10.1186/ISRCTN33302125
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Managing Injuries of the Neck
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Scientific title
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Acronym
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MINT
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Serial number at source
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HTA 02/35/02
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Study hypothesis
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To estimate the clinical and cost effectiveness of a stepped care approach following acute injury.
A related study "Managing Injuries of the Neck Trial - Incentive" is registered with ISRCTN61305297.
Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/10/2008 to 31/03/2009.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by UK Trent Multicentre Research Ethics Committee and by the Local Research Ethics Committee and the Research and Development Committee of each participating centre.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute neck sprain (whiplash)
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Participants - inclusion criteria
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1. People with Acute whiplash (<6 weeks), Whiplash Associated Disorder (WAD) grades I-III
2. Patients with persisting symptoms three weeks after their Emergency Department attendance
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Participants - exclusion criteria
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1. Age below 18
2. Fractures or dislocations of the spine and other bones
3. Head injuries with more than a transient loss of consciousness or with a Glasgow coma score of 12 or less at any stage of their assessment in hospital
4. Admission to in patient services
5. Severe psychiatric illness
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Anticipated start date
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01/11/2004
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Anticipated end date
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31/03/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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4,800 patients in first step and 600 patients in second step
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Interventions
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Stepped care approach.
1. Step One: The Whiplash Booklet versus usual care advice in Accident and Emergency (A&E)
2. Step Two: In patients with symptoms persisting at 3 weeks (WAD Grade I-III), supplementary treatment comprising either a package of physiotherapy treatments and re-enforcement of advice versus re-enforcement of advice provided at the initial A&E contact only
3. Step Three: The combined effect of the various treatments using a 2 by 2 factorial design
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Primary outcome measure(s)
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Return to normal function will be assessed using Neck Disability Index
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Secondary outcome measure(s)
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SF-12® Health Survey, Euroqol EQ-5D
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www2.warwick.ac.uk/fac/med/healthcom/emergencycare/research/whiplash/
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Publications
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1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17257408
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19700580
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23241145
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23260167
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Contact name
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Prof
Sarah Elizabeth
Lamb
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Address
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Warwick Emergergency Care & Rehabilitation
Warwick Medical School
University of Warwick
Gibbet Hill Campus
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City/town
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Coventry
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Zip/Postcode
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CV4 7AL
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Country
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United Kingdom
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Tel
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+44 (0)24 7657 4658
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Fax
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+44 (0)24 7657 4657
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Email
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s.lamb@warwick.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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02/11/2004
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Last edited
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25/02/2013
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Date ISRCTN assigned
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02/11/2004
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