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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
AVIVA Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Whiplash Injuries

Clinical Trials on Programs of Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings