University Health Network Whiplash Intervention Trial

NCT00546806 | Completed Phase 3

• 1 other identifier: 07-0623-A
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 5

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.

Conditions

Whiplash Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Global perceived recovery, Costs

  baseline, 6 weeks, 3, 6, 9 months and 1 year

Secondary Outcomes (1)

• 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

  baseline, 6 weeks, 3, 6, 9 months and 1 year

Study Arms (3)

1

EXPERIMENTAL

AVIVA "Soft Tissue Injury Care Model"

Other: Programs of Care

2

EXPERIMENTAL

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

Other: Programs of Care

3

ACTIVE COMPARATOR

Physician-based Education and Activation

Other: Programs of Care

Interventions

Programs of Care OTHER

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• AVIVA Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

Harwood Rehab and Sports Injury Clinic

Ajax, Ontario, L1S 2J5, Canada

Location

UHN Rehabilitation Solutions, Cambridge Site

Cambridge, Ontario, N3E 1B6, Canada

Location

UHN Rehabilitation Solutions, Mississauga Site

Mississauga, Ontario, L5T 2J8, Canada

Location

Pickering Rehab Clinic

Pickering, Ontario, L1V 1C3, Canada

Location

UHN Rehabilitation Solutions, Toronto Western Hospital Site

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

• 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.

  PMID: 19108741 BACKGROUND

• 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.

  PMID: 21794155 BACKGROUND

• Marchand AA, Hogg-Johnson S, Cote P. Baseline Depressive Symptoms Do Not Moderate the Association Between Baseline Symptom Severity and Time to Recovery in Individuals with Grade I-II Whiplash-Associated Disorders: A Secondary Analysis of a Randomized Controlled Trial. Am J Phys Med Rehabil. 2023 Oct 1;102(10):861-866. doi: 10.1097/PHM.0000000000002223. Epub 2023 Mar 1.

  PMID: 36882302 DERIVED

• 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.

  PMID: 30679283 DERIVED

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Study Officials

• Pierre Côté, DC, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: February 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 24, 2012

Record last verified: 2012-05

Locations

CA (5)