Whiplash InjuriesPhase 3WITNCT00546806
University Health Network Whiplash Intervention Trial
A Phase 3 study testing Programs of Care in people with Whiplash Injuries, run by University Health Network, Toronto at 5 sites in Canada.
Trial summary
Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle collisions. People with whiplash injuries often experience pain and disability that can last for a long period. This may subsequently lead to an increased use of the health care system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Programs of Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 5 sitesCanada
- Study dates
- Feb 2008to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- make an insurance claim for physical injury within 21 days of the traffic collision
- diagnosed with Grade I or Grade II WAD
- report an average neck pain since the accident of at least 3 on a 0-10 "Numerical Rating Scale"
- able to give written informed consent and complete interviews in English
Who cannot join
- a fracture/dislocation of the spine or any major bone
- head trauma associated with loss of consciousness
- past whiplash or work-related neck injury within the year prior to their current injury
- active systemic diseases
- previous neck surgery
- received treatment from a physiotherapist or a chiropractor for neck pain in the three months preceding the motor vehicle collision
- individuals who do not reside in the Greater Toronto, Mississauga, Burlington, Cambridge or Kitchener areas
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Harwood Rehab and Sports Injury Clinic
Ajax, Ontario, L1S 2J5
UHN Rehabilitation Solutions, Cambridge Site
Cambridge, Ontario, N3E 1B6
UHN Rehabilitation Solutions, Mississauga Site
Mississauga, Ontario, L5T 2J8
Pickering Rehab Clinic
Pickering, Ontario, L1V 1C3
UHN Rehabilitation Solutions, Toronto Western Hospital Site
Toronto, Ontario, M5T 2S8
About this study
Official title: The University Health Network Whiplash Intervention Trial: A Randomized Controlled Trial of the Effectiveness and Cost-effectiveness of Three Programs of Care for the Treatment of Whiplash-associated Disorders
Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle collisions. People with whiplash injuries often experience pain and disability that can last for a long period. This may subsequently lead to an increased use of the health care system. Preventing chronic symptoms is a priority for clinicians, insurers, and policy makers. However, there are very few factors that can be changed by treatment to prevent prolonged symptoms. Providing effective care at the appropriate time is one aspect that can be changed and needs to be studied. To date, no randomized clinical trials have investigated the effectiveness of multidisciplinary rehabilitation programs for the management of patients with whiplash-associated disorders. Additionally, there is no evidence to suggest whether rehabilitation programs are superior to physician-based care at improving whiplash-associated symptoms. Thus, there is a need for a randomized trial to determine what program results in the best outcomes for patients.
The purpose of this study is to compare three programs of care that are currently available in Ontario for the management of patients with Whiplash-associated disorders.
The results of this study will demonstrate which of three programs of care is superior in improving the physical and mental health of patients with whiplash-associated disorders. The results will help guide the development and implementation of effective and cost-effective programs of care by informing clinicians, insurers and government on the best rehabilitation options for patients with whiplash injuries.
Read the detailed description
Background: Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle collisions. It results in a significant burden of pain, disability and health care utilization. Preventing chronic whiplash is a priority for clinicians, insurers, and policy makers. However, whiplash injuries are resistant to treatment and few of its prognostic factors are modifiable through intervention. One of the rare factors amenable to change is the provision of timely and effective clinical care. To date, no randomized trials that have investigated the effectiveness of a coordinated and staged multidisciplinary rehabilitation program aimed at improving the health outcomes of patients with whiplash-associated disorders. Moreover, it is not known whether rehabilitation programs are superior to physician care in promoting better health outcomes. Overall, there is a need for a pragmatic randomized controlled trial to investigate what program of care yields the best outcomes for patients.
Purpose: To compare the effectiveness and cost-effectiveness of the "Soft Tissue Injury Care Model" designed by AVIVA Canada, the "Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders" recommended by the Financial Services Commission of Ontario and a physician-based "Education and Activation" intervention on the rate of self-rated recovery from whiplash-associated disorders.
Methods: We designed a three-arm pragmatic randomized controlled trial. Eligible participants will be randomly allocated to receive one of three program of care: 1) the "Soft Tissue Injury Care Model" designed by AVIVA Canada;2) the "Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders" recommended by the Financial Services Commission of Ontario ; or 3) a physician-based "Education and Activation" intervention.
Significance: The results of this study will provide evidence regarding the effectiveness of three commonly used management strategies for whiplash injuries in Ontario. The results will help guide the development of effective and cost-effective programs of care and inform insurance and government policy on the rehabilitation of whiplash injuries.
- Conditions
- Whiplash Injuries
- Being tested
- Programs of Care
- Keywords
- Rehabilitation,, Treatment outcome,, Whiplash injuries,, Randomized Clinical Trials
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programs of CareOther
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AVIVA "Soft Tissue Injury Care Model" Receives: Other: Programs of Care |
| 2 | Experimental | Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF) Receives: Other: Programs of Care |
| 3 | Active comparator | Physician-based Education and Activation Receives: Other: Programs of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global perceived recovery, Costs
Measured: baseline, 6 weeks, 3, 6, 9 months and 1 year
Secondary outcomes (1)
Neck pain intensity, Whiplash disability, Health-related quality of life, Depressive symptomatology, Satisfaction with care and satisfaction with treatment, Time on insurance benefit, Recurrence, Adverse events
Measured: baseline, 6 weeks, 3, 6, 9 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startFeb 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- AVIVA Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Pierre Côté, DC, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546806
- Sponsor's protocol ID
- 07-0623-A
- Acronym
- WIT
- Status last verified
- May 2012
- First submitted
- 18 Oct 2007
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cote P, Cassidy JD, Carette S, Boyle E, Shearer HM, Stupar M, Ammendolia C, van der Velde G, Hayden JA, Yang X, van Tulder M, Frank JW. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial. Trials. 2008 Dec 24;9:75. doi: 10.1186/1745-6215-9-75.
PubMed 19108741van der Velde G, Cote P, Bayoumi AM, Cassidy JD, Boyle E, Shearer HM, Stupar M, Jacobs C, Ammendolia C, Carette S, van Tulder M. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario. BMC Public Health. 2011 Jul 27;11:594. doi: 10.1186/1471-2458-11-594.
PubMed 21794155Marchand AA, Hogg-Johnson S, Cote P. Baseline Depressive Symptoms Do Not Moderate the Association Between Baseline Symptom Severity and Time to Recovery in Individuals with Grade I-II Whiplash-Associated Disorders: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2023 Oct 1;102(10):861-866. doi: 10.1097/PHM.0000000000002223. Epub 2023 Mar 1.
PubMed 36882302Cote P, Boyle E, Shearer HM, Stupar M, Jacobs C, Cassidy JD, Carette S, van der Velde G, Wong JJ, Hogg-Johnson S, Ammendolia C, Hayden JA, van Tulder M, Frank JW. Is a government-regulated rehabilitation guideline more effective than general practitioner education or preferred-provider rehabilitation in promoting recovery from acute whiplash-associated disorders? A pragmatic randomised controlled trial. BMJ Open. 2019 Jan 24;9(1):e021283. doi: 10.1136/bmjopen-2017-021283.
PubMed 30679283
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University Health Network Whiplash Intervention Trial: A Randomized Controlled Trial of the Effectiveness and Cost-effectiveness of Three Programs of Care for the Treatment of Whiplash-associated Disorders
- ClinicalTrials.gov ID
- NCT00546806
- Acronym / sponsor ID
- WIT / 07-0623-A
- Conditions
- Whiplash Injuries
- Keywords
- Rehabilitation,, Treatment outcome,, Whiplash injuries,, Randomized Clinical Trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- AVIVA Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Oct 2007 (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.
Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle collisions. People with whiplash injuries often experience pain and disability that can last for a long period. This may subsequently lead to an increased use of the health care system. Preventing chronic symptoms is a priority for clinicians, insurers, and policy makers. However, there are very few factors that can be changed by treatment to prevent prolonged symptoms. Providing effective care at the appropriate time is one aspect that can be changed and needs to be studied. To date, no randomized clinical trials have investigated the effectiveness of multidisciplinary rehabilitation programs for the management of patients with whiplash-associated disorders. Additionally, there is no evidence to suggest whether rehabilitation programs are superior to physician-based care at improving whiplash-associated symptoms. Thus, there is a need for a randomized trial to determine what program results in the best outcomes for patients.
The purpose of this study is to compare three programs of care that are currently available in Ontario for the management of patients with Whiplash-associated disorders.
The results of this study will demonstrate which of three programs of care is superior in improving the physical and mental health of patients with whiplash-associated disorders. The results will help guide the development and implementation of effective and cost-effective programs of care by informing clinicians, insurers and government on the best rehabilitation options for patients with whiplash injuries.
Detailed description
Background: Whiplash is the most common traffic injury, affecting 83% of people involved in motor vehicle collisions. It results in a significant burden of pain, disability and health care utilization. Preventing chronic whiplash is a priority for clinicians, insurers, and policy makers. However, whiplash injuries are resistant to treatment and few of its prognostic factors are modifiable through intervention. One of the rare factors amenable to change is the provision of timely and effective clinical care. To date, no randomized trials that have investigated the effectiveness of a coordinated and staged multidisciplinary rehabilitation program aimed at improving the health outcomes of patients with whiplash-associated disorders. Moreover, it is not known whether rehabilitation programs are superior to physician care in promoting better health outcomes. Overall, there is a need for a pragmatic randomized controlled trial to investigate what program of care yields the best outcomes for patients.
Purpose: To compare the effectiveness and cost-effectiveness of the "Soft Tissue Injury Care Model" designed by AVIVA Canada, the "Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders" recommended by the Financial Services Commission of Ontario and a physician-based "Education and Activation" intervention on the rate of self-rated recovery from whiplash-associated disorders.
Methods: We designed a three-arm pragmatic randomized controlled trial. Eligible participants will be randomly allocated to receive one of three program of care: 1) the "Soft Tissue Injury Care Model" designed by AVIVA Canada;2) the "Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders" recommended by the Financial Services Commission of Ontario ; or 3) a physician-based "Education and Activation" intervention.
Significance: The results of this study will provide evidence regarding the effectiveness of three commonly used management strategies for whiplash injuries in Ontario. The results will help guide the development of effective and cost-effective programs of care and inform insurance and government policy on the rehabilitation of whiplash injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Programs of CareAVIVA "Soft Tissue Injury Care Model" |
| 2 | Experimental | Other: Programs of CarePre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF) |
| 3 | Active comparator | Other: Programs of CarePhysician-based Education and Activation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- make an insurance claim for physical injury within 21 days of the traffic collision
- diagnosed with Grade I or Grade II WAD
- report an average neck pain since the accident of at least 3 on a 0-10 "Numerical Rating Scale"
- able to give written informed consent and complete interviews in English
Key exclusion criteria (7 listed)
- a fracture/dislocation of the spine or any major bone
- head trauma associated with loss of consciousness
- past whiplash or work-related neck injury within the year prior to their current injury
- active systemic diseases
- previous neck surgery
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 |
|---|---|---|
| Programs of CareTwo physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group. | Other | 1, 2, 3 |
Primary outcome
Global perceived recovery, Costs
Time frame: baseline, 6 weeks, 3, 6, 9 months and 1 year
1 secondary outcome
Neck pain intensity, Whiplash disability, Health-related quality of life, Depressive symptomatology, Satisfaction with care and satisfaction with treatment, Time on insurance benefit, Recurrence, Adverse events
Time frame: baseline, 6 weeks, 3, 6, 9 months and 1 year
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 24 May 2012.
- Background: PubMed 19108741Cote P, Cassidy JD, Carette S, Boyle E, Shearer HM, Stupar M, Ammendolia C, van der Velde G, Hayden JA, Yang X, van Tulder M, Frank JW. Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial. Trials. 2008 Dec 24;9:75. doi: 10.1186/1745-6215-9-75.
- Background: PubMed 21794155van der Velde G, Cote P, Bayoumi AM, Cassidy JD, Boyle E, Shearer HM, Stupar M, Jacobs C, Ammendolia C, Carette S, van Tulder M. Protocol for an economic evaluation alongside the University Health Network Whiplash Intervention Trial: cost-effectiveness of education and activation, a rehabilitation program, and the legislated standard of care for acute whiplash injury in Ontario. BMC Public Health. 2011 Jul 27;11:594. doi: 10.1186/1471-2458-11-594.
- Derived from this study: PubMed 36882302Marchand AA, Hogg-Johnson S, Cote P. Baseline Depressive Symptoms Do Not Moderate the Association Between Baseline Symptom Severity and Time to Recovery in Individuals with Grade I-II Whiplash-Associated Disorders: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2023 Oct 1;102(10):861-866. doi: 10.1097/PHM.0000000000002223. Epub 2023 Mar 1.
- Derived from this study: PubMed 30679283Cote P, Boyle E, Shearer HM, Stupar M, Jacobs C, Cassidy JD, Carette S, van der Velde G, Wong JJ, Hogg-Johnson S, Ammendolia C, Hayden JA, van Tulder M, Frank JW. Is a government-regulated rehabilitation guideline more effective than general practitioner education or preferred-provider rehabilitation in promoting recovery from acute whiplash-associated disorders? A pragmatic randomised controlled trial. BMJ Open. 2019 Jan 24;9(1):e021283. doi: 10.1136/bmjopen-2017-021283.
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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.
Pierre Côté, DC, PhD principal investigator
University Health Network, Toronto
5 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 Programs of Care in people with Whiplash Injuries, run by University Health Network, Toronto at 5 sites in Canada.
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 5 inclusion and 7 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 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Global perceived recovery, Costs (time frame: baseline, 6 weeks, 3, 6, 9 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546806, which also lists 4 linked publications.
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 24 May 2012.