University Health Network Whiplash Intervention Trial (WIT)
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| ClinicalTrials.gov Identifier: NCT00546806 |
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Recruitment Status :
Completed
First Posted : October 19, 2007
Last Update Posted : May 24, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Whiplash Injuries | Other: Programs of Care | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 340 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | February 2008 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
AVIVA "Soft Tissue Injury Care Model"
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Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group. |
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Experimental: 2
Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF)
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Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group. |
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Active Comparator: 3
Physician-based Education and Activation
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Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group. |
- Global perceived recovery, Costs [ Time Frame: baseline, 6 weeks, 3, 6, 9 months and 1 year ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546806
| Canada, Ontario | |
| Harwood Rehab and Sports Injury Clinic | |
| Ajax, Ontario, Canada, L1S 2J5 | |
| UHN Rehabilitation Solutions, Cambridge Site | |
| Cambridge, Ontario, Canada, N3E 1B6 | |
| UHN Rehabilitation Solutions, Mississauga Site | |
| Mississauga, Ontario, Canada, L5T 2J8 | |
| Pickering Rehab Clinic | |
| Pickering, Ontario, Canada, L1V 1C3 | |
| UHN Rehabilitation Solutions, Toronto Western Hospital Site | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Principal Investigator: | Pierre Côté, DC, PhD | University Health Network, Toronto |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00546806 |
| Other Study ID Numbers: |
07-0623-A |
| First Posted: | October 19, 2007 Key Record Dates |
| Last Update Posted: | May 24, 2012 |
| Last Verified: | May 2012 |
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Rehabilitation, Treatment outcome, Whiplash injuries, Randomized Clinical Trials |
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Whiplash Injuries Neck Injuries Wounds and Injuries |