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

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ClinicalTrials.gov Identifier: NCT00206271
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Danish Pain Research Center
Information provided by:
The Back Research Center, Denmark

Brief Summary:

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 or disease Intervention/treatment Phase
Whiplash Injury Behavioral: neck collar; advice to act-as-usual; active mobilisation Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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.
Study Start Date : May 2001
Estimated Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Neck pain intensity
  2. Headache intensity
  3. Neck disability
  4. Sick leave during the 12 month after inclusion

Secondary Outcome Measures :
  1. Medication
  2. Number of non-painful complaints
  3. General health

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206271

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

ClinicalTrials.gov Identifier: NCT00206271     History of Changes
Other Study ID Numbers: 20000268
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005

Keywords provided by The Back Research Center, Denmark:
whiplash injuries
neck pain
exercise movement techniques

Additional relevant MeSH terms:
Wounds and Injuries
Whiplash Injuries
Neck Injuries