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| Name | Class |
|---|---|
| AVIVA Canada | UNKNOWN |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AVIVA "Soft Tissue Injury Care Model" |
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| 2 | Experimental | Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF) |
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| 3 | Active Comparator | Physician-based Education and Activation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programs of Care | Other | Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global perceived recovery, Costs | baseline, 6 weeks, 3, 6, 9 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 6 weeks, 3, 6, 9 months and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Côté, DC, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harwood Rehab and Sports Injury Clinic | Ajax | Ontario | L1S 2J5 | Canada | ||
| UHN Rehabilitation Solutions, Cambridge Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19108741 | Background | 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. | |
| 21794155 |
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| ID | Term |
|---|---|
| D014911 | Whiplash Injuries |
| ID | Term |
|---|---|
| D019838 | Neck Injuries |
| D014947 | Wounds and Injuries |
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| Cambridge |
| Ontario |
| N3E 1B6 |
| Canada |
| UHN Rehabilitation Solutions, Mississauga Site | Mississauga | Ontario | L5T 2J8 | Canada |
| Pickering Rehab Clinic | Pickering | Ontario | L1V 1C3 | Canada |
| UHN Rehabilitation Solutions, Toronto Western Hospital Site | Toronto | Ontario | M5T 2S8 | Canada |
| Background |
| van 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. |
| 36882302 | Derived | Marchand 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. |
| 30679283 | Derived | Cote 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. |