Managing Injuries of the Neck
| 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
Contact information
Prof Sarah Elizabeth Lamb
Scientific
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 |
|---|---|
| s.lamb@warwick.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Return to normal function will be assessed using Neck Disability Index |
| Secondary outcome measures | SF-12® Health Survey, Euroqol EQ-5D |
| Overall study start date | 01/11/2004 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 4,800 patients in first step and 600 patients in second step |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Emergergency Care & Rehabilitation
Coventry
CV4 7AL
United Kingdom
CV4 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
