Plain English Summary
Not provided at time of registration
Trial website
http://www2.warwick.ac.uk/fac/med/healthcom/emergencycare/research/whiplash/
Contact information
Type
Scientific
Primary contact
Prof Sarah Elizabeth Lamb
ORCID ID
Contact details
Warwick Emergergency Care & Rehabilitation
Warwick Medical School
University of Warwick
Gibbet Hill Campus
Coventry
CV4 7AL
United Kingdom
+44 (0)24 7657 4658
s.lamb@warwick.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 02/35/02
Study information
Scientific title
Acronym
MINT
Study hypothesis
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.
Ethics approval
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.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute neck sprain (whiplash)
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Return to normal function will be assessed using Neck Disability Index
Secondary outcome measures
SF-12® Health Survey, Euroqol EQ-5D
Overall trial start date
01/11/2004
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4,800 patients in first step and 600 patients in second step
Participant exclusion criteria
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
Recruitment start date
01/11/2004
Recruitment end date
31/03/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warwick Emergergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Lamb SE, Williams MA, Withers E, Perry J, Gates S, Williamson E, Underwood M, Cooke M, A national survey of clinical practice for the management of whiplash-associated disorders in UK emergency departments., Emerg Med J, 2009, 26, 9, 644-647, doi: 10.1136/emj.2008.065276.
-
Results
Lamb SE, Williams MA, Williamson EM, Gates S, Withers EJ, Mt-Isa S, Ashby D, Castelnuovo E, Underwood M, Cooke MW, , Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries., Health Technol Assess, 2012, 16, 49, iii-iv, 1-141, doi: 10.3310/hta16490.
-
Results
Lamb SE, Gates S, Williams MA, Williamson EM, Mt-Isa S, Withers EJ, Castelnuovo E, Smith J, Ashby D, Cooke MW, Petrou S, Underwood MR, , Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial., Lancet, 2013, 381, 9866, 546-556, doi: 10.1016/S0140-6736(12)61304-X.
-
Lamb SE, Gates S, Underwood MR, Cooke MW, Ashby D, Szczepura A, Williams MA, Williamson EM, Withers EJ, Mt Isa S, Gumber A, , Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders., BMC Musculoskelet Disord, 2007, 8, 7, doi: 10.1186/1471-2474-8-7.