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Completed

NCT Number: NCT00206271

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

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Key information

Conditions

Whiplash Injury Neck Injuries Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Whiplash Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Back Research Center, 5750 Ringe, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neck collar; advice to act-as-usual; active mobilisation

Behavioral

Primary outcomes

  1. Neck pain intensity

  2. Headache intensity

  3. Neck disability

  4. Sick leave during the 12 month after inclusion

Secondary outcomes

  1. Medication

  2. Number of non-painful complaints

  3. General health

Sponsors and collaborators

Lead sponsor

The Back Research Center, Denmark

Other

Collaborators

  • Danish Pain Research Center

Registry information

Official study 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.

Important dates

Study start
2001
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Sep 21, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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