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

Whiplash Injury Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206271
• Other study ID #: 20000268
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: May 2001
• Est. completion date: October 2004

Study information

• Verified date: September 2005
• Source: The Back Research Center, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Whiplash Injuries
• Whiplash Injury

Intervention

Behavioral:
• neck collar; advice to act-as-usual; active mobilisation

Locations

Country	Name	City	State
Denmark	The Back Research Center	5750 Ringe
Denmark	Danish Pain Research Center	8000 Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
The Back Research Center, Denmark	Danish Pain Research Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain intensity
Primary	Headache intensity
Primary	Neck disability
Primary	Sick leave during the 12 month after inclusion
Secondary	Medication
Secondary	Number of non-painful complaints
Secondary	General health