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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:
Collaborator:
Danish Pain Research Center
Information provided by:
The Back Research Center, Denmark
ClinicalTrials.gov Identifier:
NCT00206271
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00206271     History of Changes
Other Study ID Numbers: 20000268
Study First Received: September 13, 2005
Last Updated: September 13, 2005
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

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

ClinicalTrials.gov processed this record on May 19, 2013