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

Sponsor

The Back Research Center, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT00206271

Collaborator

Danish Pain Research Center (Other)

450

Enrollment

Locations

Duration (Months)

225

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Whiplash Injury	Behavioral: neck collar; advice to act-as-usual; active mobilisation	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

May 1, 2001

Study Completion Date :

Oct 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Medication []
Number of non-painful complaints []
General health []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.