University Health Network Whiplash Intervention Trial - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto AVIVA Canada CIHR
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00546806

Purpose

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	Intervention	Phase
Whiplash Injuries	Other: Programs of Care	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Global perceived recovery, Costs [ Time Frame: baseline, 6 weeks, 3, 6, 9 months and 1 year ] [ Designated as safety issue: No ]

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 [ Time Frame: baseline, 6 weeks, 3, 6, 9 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	444
Study Start Date:	February 2008
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546806

Contacts

Contact: Angela Verven-Perrucio, BA

(416) 603-5800 ext 6086

averven@uhnresearch.ca

Locations

Canada, Ontario
UHN Rehabilitation Solutions, Toronto Western Hospital Site	Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Maja Stupar, BSc, DC (416) 562-1634 mstupar@uhnresearch.ca
UHN Rehabilitation Solutions, Mississauga Site	Recruiting
Mississauga, Ontario, Canada, L5T 2J8
Contact: Heather Shearer, BA(Hons), DC (416) 564-2019 hshearer@uhnresearch.ca
UHN Rehabilitation Solutions, Cambridge Site	Recruiting
Cambridge, Ontario, Canada, N3E 1B6
Contact: Heather Shearer, BA(Hons), DC (416) 564-2019 hshearer@uhnresearch.ca

Sponsors and Collaborators

University Health Network, Toronto

AVIVA Canada

CIHR

Investigators

Principal Investigator:

Pierre Côté, DC, PhD

University Health Network, Toronto

More Information

Publications:

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(1):75 [Epub ahead of print]

Responsible Party:	University Health Network ( Dr. Pierre Côté )
Study ID Numbers:	07-0623-A
Study First Received:	October 18, 2007
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00546806 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Rehabilitation,
Treatment outcome,
Whiplash injuries,
Randomized Clinical Trials

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Neck Injuries
Whiplash Injuries

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Neck Injuries
Whiplash Injuries

ClinicalTrials.gov processed this record on July 02, 2009