Condition category
Musculoskeletal Diseases
Date applied
26/02/2008
Date assigned
29/02/2008
Last edited
02/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.if-insurance.com

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

  1. 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.

Additional files

Editorial Notes