Contact information
Type
Scientific
Primary contact
Dr Jens Ivar Brox
ORCID ID
Contact details
Section for Back Surgery and Physical Medicine and Rehabilitation
Orthopaedic Department
Rikshospitalet University Hospital
Oslo
N-0027
Norway
jens.ivar.brox@rikshospitalet.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Patients with whiplash injuries showing minimal improvement 4 weeks or more following a minor or moderate traffic injury would benefit from multidisciplinary evaluation and advice as compared to treatment as usual.
Ethics approval
Regional Committee for Medical Research Ethics, Health Region 2, Norway and the Data Inspectorate, Norway. Date of approval: 24/09/1999 (ref: 99/1964-2)
Study design
Observational prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Whiplash-associated disorders
Intervention
Multidisciplinary evaluation and advice. The intervention consisted of a thorough clinical examination by a general practitioner, who had special training and experience with whiplash-associated disorders, as well as comprehensive testing by physiotherapists with special education in manual therapy. This examination took approximately 2.5 hours. Following the completion of this examination, the injured were referred to a more specialized assessment when necessary. Eighty-five percent of the participants were examined further by a specialist, most often a rehabilitation specialist (50%) or a neurologist (30%).
Comparator: treatment as usual
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following were assessed by a follow-up questionnaire at three years post-injury:
1. Frequency of neck pain (never, sometimes and daily)
2. Severity of neck pain (very severe, severe, moderate and mild)
Secondary outcome measures
The following were assessed by a follow-up questionnaire at three years post-injury:
1. Current employment status
2. Physical functioning
3. Customer satisfaction
Overall trial start date
01/07/1996
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 16 years or older
2. Those who reported a traffic accident injury to If P&C Insurance Company Ltd.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
700
Participant exclusion criteria
Patients with a injury to the brain (except concussion), cranial nerves, spinal cord, eyes, abdominal organs, or with multiple traumas.
Recruitment start date
01/07/1996
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Norway
Trial participating centre
Section for Back Surgery and Physical Medicine and Rehabilitation
Oslo
N-0027
Norway
Sponsor information
Organisation
If P&C Insurance Company (Norway)
Sponsor details
P.O. Box 240
1326
Lysaker
N-1326
Norway
postmottak@if.no
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
If P&C Insurance Company (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Omnia Hospital, Oslo (Norway)
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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16934210
Publication citations
-
Results
Pape E, Brox JI, Hagen KB, Natvig B, Schirmer H, Prognostic factors for chronic neck pain in persons with minor or moderate injuries in traffic accidents., Accid Anal Prev, 2007, 39, 1, 135-146, doi: 10.1016/j.aap.2006.06.010.