Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
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.
1 other identifier
interventional
450
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2001
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedSeptember 21, 2005
September 1, 2005
September 13, 2005
September 13, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Neck pain intensity
Headache intensity
Neck disability
Sick leave during the 12 month after inclusion
Secondary Outcomes (3)
Medication
Number of non-painful complaints
General health
Interventions
Eligibility Criteria
You may qualify if:
- Been exposed to rear-end or frontal car collision
- Experienced symptoms within 72 hours
- years
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Back Research Center, Denmarklead
- Danish Pain Research Centercollaborator
Study Sites (2)
The Back Research Center
5750 Ringe, Denmark
Danish Pain Research Center
8000 Aarhus, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tom Bendix
The Back Research Center
- STUDY CHAIR
Troels S Jensen
Danish Pain Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2001
Study Completion
October 1, 2004
Last Updated
September 21, 2005
Record last verified: 2005-09