University Health Network Whiplash Intervention Trial (WIT)

May 23, 2012 updated by: University Health Network, Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Harwood Rehab and Sports Injury Clinic
      • Cambridge, Ontario, Canada, N3E 1B6
        • UHN Rehabilitation Solutions, Cambridge Site
      • Mississauga, Ontario, Canada, L5T 2J8
        • UHN Rehabilitation Solutions, Mississauga Site
      • Pickering, Ontario, Canada, L1V 1C3
        • Pickering Rehab Clinic
      • Toronto, Ontario, Canada, M5T 2S8
        • UHN Rehabilitation Solutions, Toronto Western Hospital Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AVIVA "Soft Tissue Injury Care Model"
Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
Experimental: 2
Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF)
Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
Active Comparator: 3
Physician-based Education and Activation
Other: Programs of Care
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global perceived recovery, Costs
Time Frame: baseline, 6 weeks, 3, 6, 9 months and 1 year
baseline, 6 weeks, 3, 6, 9 months and 1 year

Secondary Outcome Measures

Outcome Measure
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
Time Frame: baseline, 6 weeks, 3, 6, 9 months and 1 year
baseline, 6 weeks, 3, 6, 9 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
AVIVA Canada

Investigators

  • Principal Investigator: Pierre Côté, DC, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 24, 2012

Last Update Submitted That Met QC Criteria

May 23, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0623-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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