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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00206271
First Posted: September 21, 2005
Last Update Posted: December 9, 2005
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danish Pain Research Center
Information provided by:
The Back Research Center, Denmark
September 13, 2005
September 21, 2005
December 9, 2005
May 2001
Not Provided
  • Neck pain intensity
  • Headache intensity
  • Neck disability
  • Sick leave during the 12 month after inclusion
Same as current
No Changes Posted
  • Medication
  • Number of non-painful complaints
  • General health
Same as current
Not Provided
Not Provided
 
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Whiplash Injury
Behavioral: neck collar; advice to act-as-usual; active mobilisation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
October 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00206271
20000268
Not Provided
Not Provided
Not Provided
Not Provided
The Back Research Center, Denmark
Danish Pain Research Center
Study Chair: Tom Bendix The Back Research Center
Study Chair: Troels S Jensen Danish Pain Research Center
The Back Research Center, Denmark
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP