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University Health Network Whiplash Intervention Trial (WIT)

Primary Purpose

Whiplash Injuries

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Programs of Care
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Injuries focused on measuring Rehabilitation,, Treatment outcome,, Whiplash injuries,, Randomized Clinical Trials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harwood Rehab and Sports Injury Clinic
  • UHN Rehabilitation Solutions, Cambridge Site
  • UHN Rehabilitation Solutions, Mississauga Site
  • Pickering Rehab Clinic
  • UHN Rehabilitation Solutions, Toronto Western Hospital Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

AVIVA "Soft Tissue Injury Care Model"

Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF)

Physician-based Education and Activation

Outcomes

Primary Outcome Measures

Global perceived recovery, Costs

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2007
Last Updated
May 23, 2012
Sponsor
University Health Network, Toronto
Collaborators
AVIVA Canada, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00546806
Brief Title
University Health Network Whiplash Intervention Trial
Acronym
WIT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
AVIVA Canada, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
Rehabilitation,, Treatment outcome,, Whiplash injuries,, Randomized Clinical Trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AVIVA "Soft Tissue Injury Care Model"
Arm Title
2
Arm Type
Experimental
Arm Description
Pre-approved Framework Guideline for Grade I and II Whiplash Associated Disorders (PAF)
Arm Title
3
Arm Type
Active Comparator
Arm Description
Physician-based Education and Activation
Intervention Type
Other
Intervention Name(s)
Programs of Care
Intervention Description
Two physiotherapy programs of care for the experimental groups; Physician-based education and activation for the active comparator group.
Primary Outcome Measure Information:
Title
Global perceived recovery, Costs
Time Frame
baseline, 6 weeks, 3, 6, 9 months and 1 year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Côté, DC, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harwood Rehab and Sports Injury Clinic
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
UHN Rehabilitation Solutions, Cambridge Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N3E 1B6
Country
Canada
Facility Name
UHN Rehabilitation Solutions, Mississauga Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5T 2J8
Country
Canada
Facility Name
Pickering Rehab Clinic
City
Pickering
State/Province
Ontario
ZIP/Postal Code
L1V 1C3
Country
Canada
Facility Name
UHN Rehabilitation Solutions, Toronto Western Hospital Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19108741
Citation
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.
Results Reference
background
PubMed Identifier
21794155
Citation
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.
Results Reference
background
PubMed Identifier
30679283
Citation
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.
Results Reference
derived

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University Health Network Whiplash Intervention Trial

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