Whiplash InjuryPhase 3NCT00206271
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
A Phase 3 study testing neck collar; advice to act-as-usual; active mobilisation in people with Whiplash Injury, run by The Back Research Center, Denmark at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Whiplash Injury
- What is being tested?
- neck collar; advice to act-as-usual; active mobilisation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2001to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Been exposed to rear-end or frontal car collision
- Experienced symptoms within 72 hours
- 18 - 70 years
Who cannot join
- 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
Show all 9Show fewer
- Significant pre-existing somatic or psychiatric disease
- Alcohol or drug abuse
- Does not read or understand Danish.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
The Back Research Center
5750 Ringe
Danish Pain Research Center
8000 Aarhus
About this study
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.
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.
- Conditions
- Whiplash Injury
- Being tested
- neck collar; advice to act-as-usual; active mobilisation
- Keywords
- whiplash injuries, neck pain, exercise movement techniques, immobilisation
- Medical subject headings
- Whiplash Injuries, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck collar; advice to act-as-usual; active mobilisationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity
Headache intensity
Neck disability
Sick leave during the 12 month after inclusion
Secondary outcomes (3)
Medication
Number of non-painful complaints
General health
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2001
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- The Back Research Center, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Pain Research Center
- Investigators
- Tom Bendix, Study chair, The Back Research CenterTroels S Jensen, Study chair, Danish Pain Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206271
- Sponsor's protocol ID
- 20000268
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00206271
- Acronym / sponsor ID
- 20000268
- Conditions
- Whiplash Injury
- Keywords
- whiplash injuries, neck pain, exercise movement techniques, immobilisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- The Back Research Center, DenmarkUniversity, hospital or other
- Collaborators
- Danish Pain Research Center
- Study start
- May 2001
- Study completion
- Oct 2004
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Been exposed to rear-end or frontal car collision
- Experienced symptoms within 72 hours
- 18 - 70 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neck collar; advice to act-as-usual; active mobilisation | Behavioural | – |
Primary outcome
Neck pain intensity
Headache intensity
Neck disability
Sick leave during the 12 month after inclusion
3 secondary outcomes
Medication
Number of non-painful complaints
General health
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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Virtual Reality Rehabilitation in Neck Pain Subjects
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Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Bendix study chair
The Back Research Center
Troels S Jensen study chair
Danish Pain Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing neck collar; advice to act-as-usual; active mobilisation in people with Whiplash Injury, run by The Back Research Center, Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005; AzTrials last refreshed its copy on 7 Nov 2026.