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

Primary Purpose

Whiplash Injury

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
neck collar; advice to act-as-usual; active mobilisation
Sponsored by
The Back Research Center, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injury focused on measuring whiplash injuries, neck pain, exercise movement techniques, immobilisation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Back Research Center
  • Danish Pain Research Center

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
The Back Research Center, Denmark
Collaborators
Danish Pain Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00206271
Brief Title
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
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 Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Back Research Center, Denmark
Collaborators
Danish Pain Research Center

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injury
Keywords
whiplash injuries, neck pain, exercise movement techniques, immobilisation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
neck collar; advice to act-as-usual; active mobilisation
Primary Outcome Measure Information:
Title
Neck pain intensity
Title
Headache intensity
Title
Neck disability
Title
Sick leave during the 12 month after inclusion
Secondary Outcome Measure Information:
Title
Medication
Title
Number of non-painful complaints
Title
General health

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Bendix
Organizational Affiliation
The Back Research Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Troels S Jensen
Organizational Affiliation
Danish Pain Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
The Back Research Center
City
5750 Ringe
Country
Denmark
Facility Name
Danish Pain Research Center
City
8000 Aarhus
Country
Denmark

12. IPD Sharing Statement

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

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