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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

May 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Medication
Number of non-painful complaints
General health

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Whiplash Injury

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

450

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00206271

Responsible Party

Study ID Numbers ^ICMJE

20000268

Study Sponsor ^ICMJE

The Back Research Center, Denmark

Collaborators ^ICMJE

Danish Pain Research Center

Investigators ^ICMJE

Study Chair:	Tom Bendix	The Back Research Center
Study Chair:	Troels S Jensen	Danish Pain Research Center

Information Provided By

The Back Research Center, Denmark

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP