Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury

This study has been completed.

First Received: September 13, 2005 No Changes Posted

Sponsors and Collaborators:	The Back Research Center, Denmark Danish Pain Research Center
Information provided by:	The Back Research Center, Denmark
ClinicalTrials.gov Identifier:	NCT00206271

Purpose

Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms behind WAD are virtually unknown, as are the possible effects of early intervention. This trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic WAD following acute whiplash injury.

Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.

Condition	Intervention	Phase
Whiplash Injury	Behavioral: neck collar; advice to act-as-usual; active mobilisation	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Early Intervention Study Comparing the Effect of Stiff Neck Collar, “Act-as-Usual” and Active Mobilisation on the One Year Outcome Following Whiplash Injury.

Resource links provided by NLM:

MedlinePlus related topics: Headache Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by The Back Research Center, Denmark:

Primary Outcome Measures:

Neck pain intensity
Headache intensity
Neck disability
Sick leave during the 12 month after inclusion

Secondary Outcome Measures:

Medication
Number of non-painful complaints
General health

Estimated Enrollment:	450
Study Start Date:	May 2001
Estimated Study Completion Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Been exposed to rear-end or frontal car collision
Experienced symptoms within 72 hours
18 – 70 years

Exclusion Criteria:

Could not be enrolled within 10 days of the collision
Fractures or dislocations of the cervical spine
Amnesia for the accident
Unconsciousness in relation to the accident
Injuries other than the whiplash injury
Average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain
Significant pre-existing somatic or psychiatric disease
Alcohol or drug abuse
Does not read or understand Danish.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206271

Locations

Denmark
The Back Research Center
5750 Ringe, Denmark
Danish Pain Research Center
8000 Aarhus, Denmark

Sponsors and Collaborators

The Back Research Center, Denmark

Danish Pain Research Center

Investigators

Study Chair:	Tom Bendix	The Back Research Center
Study Chair:	Troels S Jensen	Danish Pain Research Center

More Information

No publications provided

Study ID Numbers:	20000268
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00206271 History of Changes
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by The Back Research Center, Denmark:

whiplash injuries
neck pain
exercise movement techniques
immobilisation

Study placed in the following topic categories:

Neck Pain
Wounds and Injuries
Disorders of Environmental Origin

Pain
Neck Injuries
Whiplash Injuries

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Neck Injuries
Whiplash Injuries

ClinicalTrials.gov processed this record on July 06, 2009