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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206271

Enrollment

450

Registered

2005-09-21

Start date

2001-05-31

Completion date

2004-10-31

Last updated

2005-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whiplash Injury

Keywords

whiplash injuries, neck pain, exercise movement techniques, immobilisation

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Neck pain intensity	—
Headache intensity	—
Neck disability	—
Sick leave during the 12 month after inclusion	—

Secondary

Measure	Time frame
Number of non-painful complaints	—
General health	—
Medication	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026