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

September 13, 2005 updated by: The Back Research Center, Denmark

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • 5750 Ringe, Denmark
        • The Back Research Center
      • 8000 Aarhus, Denmark
        • Danish Pain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Medication
Number of non-painful complaints
General health

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Back Research Center, Denmark

Collaborators

Danish Pain Research Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion

December 6, 2022

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 21, 2005

Last Update Submitted That Met QC Criteria

September 13, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20000268

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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