Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000157673
Ethics application status
Approved
Date submitted
4/02/2014
Date registered
10/02/2014
Date last updated
10/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Characterising whiplash injury using magnetic resonance imaging
Scientific title
Quantification of cervical spine structural changes using magnetic resonance imaging following neck pain and injury caused by motor vehicle accident
Secondary ID [1] 282137 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash 288636 0
Condition category
Condition code
Musculoskeletal 288976 288976 0 0
Other muscular and skeletal disorders
Injuries and Accidents 291446 291446 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnetic resonance imaging of the cervical spine (20-30 min) - one appointment following recruitment
Intervention code [1] 286744 0
Diagnosis / Prognosis
Comparator / control treatment
Control participant group with no neck pain and disability caused by motor vehicle accident (i.e. no whiplash injury).Magnetic resonance imaging of the cervical spine (20-30 min) - one appointment following recruitment
Control group
Active

Outcomes
Primary outcome [1] 289098 0
Cervical spine morphometry measured from magnetic resonance images
Timepoint [1] 289098 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [1] 301771 0
Neck disability index
Timepoint [1] 301771 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [2] 301772 0
Visual Analog Scale - neck pain and headache
Timepoint [2] 301772 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [3] 301773 0
Assessment of Quality of Life instrument
Timepoint [3] 301773 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [4] 301774 0
Impact of events scale
Timepoint [4] 301774 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [5] 301775 0
Cervical range of motion using a goniometer
Timepoint [5] 301775 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident
Secondary outcome [6] 301776 0
Pain thresholds using an algometer
Timepoint [6] 301776 0
Control group - at the time of recruitment; Acute whiplash group - <2 weeks following motor vehicle accident; Chronic whiplash group - > 3 months < 3 years following motor vehicle accident

Eligibility
Key inclusion criteria
Whiplash subjects - whiplash associated disorder (WAD) II with neck pain and disability caused by a motor vehicle accident <2 weeks since crash (acute) OR >12 weeks & <3 years since crash (chronic)
Control subjects - no neck pain or disability caused by a motor vehicle accident
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
WAD 0, I, III and IV
Previous history of whiplash injury, spinal surgery, spinal joint disease
Pregnancy
Contraindications to MR scanning

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 286906 0
Hospital
Name [1] 286906 0
Private Practice Fund, The Canberra Hospital
Country [1] 286906 0
Australia
Funding source category [2] 286907 0
Charities/Societies/Foundations
Name [2] 286907 0
Royal Australian and New Zealand College of Radiologists
Country [2] 286907 0
Australia
Primary sponsor type
Hospital
Name
ACT Health
Address

ACT Health HREC
Building 10 Level 6
Yamba Drive
Canberra Hospital
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 285694 0
University
Name [1] 285694 0
Australian National University
Address [1] 285694 0
Research Services
Chancelry 10B
East Road
The Australian National University
Acton ACT 0200
Country [1] 285694 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288965 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 288965 0
Human Research Ethics Committee
ACT Health Research Office
Level 6, Building 10
Canberra Hospital
Garran ACT 2605
Ethics committee country [1] 288965 0
Australia
Date submitted for ethics approval [1] 288965 0
Approval date [1] 288965 0
19/12/2012
Ethics approval number [1] 288965 0
ETH.11.12.285
Ethics committee name [2] 288966 0
ANU Human Research Ethics Committee
Ethics committee address [2] 288966 0
Research Services
Chancelry 10B
East Road
The Australian National University
Acton ACT 0200
Ethics committee country [2] 288966 0
Australia
Date submitted for ethics approval [2] 288966 0
Approval date [2] 288966 0
22/02/2013
Ethics approval number [2] 288966 0
2013/015

Summary
Brief summary
Injuries to the neck following whiplash trauma (whiplash injury) are one of the most common causes of neck pain and disability in the developed world. The purpose of this study is to investigate the use of magnetic resonance (MR) imaging in combination with physical and psychological measures, to identify structural lesions of the neck following whiplash injury. The ability to identify and differentiate the relationship between structural lesions and physical and psychosocial measures in whiplash patients will potentially enable more specific and timely management thereby potentially reducing the number of patients who develop chronic symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38550 0
Dr Alexandra Webb
Address 38550 0
Medical School, Peter Baume Building 42, Australian National University, Canberra, ACT 0200
Country 38550 0
Australia
Phone 38550 0
Tel: +61 (0)2 6244 3701
Fax 38550 0
Email 38550 0
[email protected]
Contact person for public queries
Name 38551 0
Dr Diana Perriman
Address 38551 0
Trauma & Orthopaedic Research Unit
The Canberra Hospital
PO Box 11
Woden, ACT, 2606
AUSTRALIA
Country 38551 0
Australia
Phone 38551 0
Tel: +61 (0)2 6244 3701
Fax 38551 0
Email 38551 0
[email protected]
Contact person for scientific queries
Name 38552 0
Dr Diana Perriman
Address 38552 0
Trauma & Orthopaedic Research Unit
The Canberra Hospital
PO Box 11
Woden, ACT, 2606
AUSTRALIA
Country 38552 0
Australia
Phone 38552 0
Tel: +61 (0)2 6244 3701
Fax 38552 0
Email 38552 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.