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

NCT ID: NCT00206271

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2004-10-31

Brief Summary

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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

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Conditions

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Whiplash Injury

Keywords

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whiplash injuries neck pain exercise movement techniques immobilisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Pain Research Center

OTHER

Sponsor Role collaborator

The Back Research Center, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Tom Bendix

Role: STUDY_CHAIR

The Back Research Center

Troels S Jensen

Role: STUDY_CHAIR

Danish Pain Research Center

Locations

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The Back Research Center

5750 Ringe, , Denmark

Site Status

Danish Pain Research Center

8000 Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20000268

Identifier Type: -

Identifier Source: org_study_id