Managing Injuries of the Neck

ISRCTN	ISRCTN33302125
DOI	https://doi.org/10.1186/ISRCTN33302125
Protocol serial number	HTA 02/35/02
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MINT
Study objectives	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(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) studied	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
Primary outcome measure(s)	Return to normal function will be assessed using Neck Disability Index
Key secondary outcome measure(s)	SF-12® Health Survey, Euroqol EQ-5D
Completion date	31/03/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	5400
Key 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
Key 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
Date of first enrolment	01/11/2004
Date of final enrolment	31/03/2009

Warwick Emergergency Care & Rehabilitation

Coventry
CV4 7AL
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No
Results article	results	01/09/2012		Yes	No
Results article	results	16/02/2013		Yes	No
Protocol article	protocol	26/01/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes