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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Editorial Notes