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University Health Network Whiplash Intervention Trial

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00546806
Acronym
WIT
Enrollment
340
Registered
2007-10-19
Start date
2008-02-29
Completion date
2012-05-31
Last updated
2012-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Whiplash Injuries

Keywords

Rehabilitation,, Treatment outcome,, Whiplash injuries,, Randomized Clinical Trials

Brief 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. 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.

Interventions

OTHERPrograms of Care

Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.

Sponsors

AVIVA Canada
CollaboratorUNKNOWN
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Global perceived recovery, Costsbaseline, 6 weeks, 3, 6, 9 months and 1 year

Secondary

MeasureTime 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 eventsbaseline, 6 weeks, 3, 6, 9 months and 1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026