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

Phase 3

Completed

• Conditions: Whiplash Injury

• Registration Number: NCT00206271
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study Completion: 2004-10
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Posted: 2005-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck disability
Neck pain intensity
Headache intensity
Sick leave during the 12 month after inclusion

Secondary Outcome Measures

Name	Time	Method
Number of non-painful complaints
Medication
General health

Trial Locations

Locations (2)

The Back Research Center; 🇩🇰 5750 Ringe, Denmark

Danish Pain Research Center; 🇩🇰 8000 Aarhus, Denmark