ISRCTN ISRCTN33302125
DOI https://doi.org/10.1186/ISRCTN33302125
Secondary identifying numbers HTA 02/35/02
Submission date
02/11/2004
Registration date
02/11/2004
Last edited
25/02/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Sarah Elizabeth Lamb
Scientific

Warwick Emergergency Care & Rehabilitation
Warwick Medical School
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom

Phone +44 (0)24 7657 4658
Email s.lamb@warwick.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMINT
Study objectivesTo 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.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedAcute neck sprain (whiplash)
InterventionStepped 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
Intervention typeOther
Primary outcome measureReturn to normal function will be assessed using Neck Disability Index
Secondary outcome measuresSF-12® Health Survey, Euroqol EQ-5D
Overall study start date01/11/2004
Completion date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants4,800 patients in first step and 600 patients in second step
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2004
Date of final enrolment31/03/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Warwick Emergergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/01/2007 Yes No
Results article results 01/09/2009 Yes No
Results article results 01/09/2012 Yes No
Results article results 16/02/2013 Yes No