Effectiveness of an Educational Video Following Acute Whiplash Trauma
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|ClinicalTrials.gov Identifier: NCT01699334|
Recruitment Status : Recruiting
First Posted : October 3, 2012
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment|
|Whiplash Injuries||Behavioral: Psychoeducational video Other: Relaxation video|
Whiplash injuries affect 1-3 per 1000 inhabitants each year (Jansen et al. 2008). Most patients only experience transitory neck complaints and recover within weeks. However, an estimated 10% will develop severe persistent pain seriously affecting long term well-being and work ability. The exact mechanisms behind the variation in recovery remain elusive, and our knowledge on how to prevent the transition from acute to chronic neck pain is sparse. Guidelines for management of acute whiplash emphasize the importance of patient information, but there is limited evidence as to how information should be provided in order to improve recovery. Nevertheless, recent studies indicate that patient education by video may be a beneficial method to improve early management of neck pain (Oliveira et al. 2006, Brison et al. 2005).
Using a randomized controlled design this study aims to determine the efficacy of an educational video concerning whiplash injuries in comparison with an active comparator condition consisting of a relaxation video. The anticipated study population is 300 consecutive patients with acute neck complaints following motor vehicle accidents recruited at two major Emergency Departments in Denmark.
Following completion of the standard care in the emergency room, patients who have given consent to participate are randomized to either intervention (educational video) or comparison group (relaxation video). Randomization is achieved by emergency room staff handing out sequentially numbered, sealed envelopes, which have been prepared at the Research Clinic for Functional Disorders and Psychosomatics. The randomization list is computer-generated in blocks of 20 and stratified according to place of treatment (participating emergency wards). The envelope contains a letter with a personal code giving the participant access to a secure website on which to view the video at home.
The educational video will explain the nature of whiplash injuries and provide a biopsychosocial model for neck pain incorporating both physiological and cognitive-behavioural aspects, reassurance and basic advice on pain relief. The comparison condition is a relaxation video detailing simple relaxation exercises such as breathing exercises which can be safely used by whiplash patients. The relaxation video contains no explanatory information concerning whiplash injuries or the related symptoms.
The participants are followed for 12 months after visiting the emergency room. Self-report data are obtained from questionnaires at 1-week, 3- and 12-month follow-up. Data on health care use and absence from work due to illness will be retrieved from public registers throughout the follow-up period. The study has been approved by The Central Region Committees on Biomedical Research Ethics, Denmark and the Danish Data Protection Agency. The project is funded by a single grant from the Tryg Foundation, Denmark.
The transition from acute to chronic pain after whiplash trauma poses a threat to the well-being of the individual as well as leading to extensive health care costs and loss of work days (Leth-Petersen & Rotger 2009, Holm et al. 1999). The development of cost-effective preventive interventions which can be added to the usual treatment in the early stages of whiplash associated disorders could potentially contribute to reducing suffering for patients and financial costs for society. This study will hopefully contribute to the development of effective and evidence-based treatment of whiplash associated disorders. In the long term, the study may also aid the development of patient education for other patient groups at risk of developing a chronic disorder.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2018|
|Experimental: Psychoeducational video||
Behavioral: Psychoeducational video
The educational video will explain the nature of whiplash injuries and provide a biopsychosocial model for neck pain incorporating both physiological and cognitive-behavioural aspects, reassurance and basic advice on pain relief.
|Active Comparator: Relaxation video||
Other: Relaxation video
The comparison condition is a relaxation video detailing simple relaxation exercises such as breathing exercises which can be safely used by whiplash patients. The relaxation video contains no explanatory information concerning whiplash injuries or the related symptoms.
- Intensity of neck pain [ Time Frame: 3 months after visit to emergency room ]11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)
- Self-rated level of recovery (Patient Global Impression of Change) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Self-rated physical level of functioning (SF-36) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Self-rated neck disability (Copenhagen Neck Functional Disability Scale) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Illness perceptions (The Brief Illness Perceptions Questionnaire) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Pain-related fear of movement (The Tampa Scale for Kinesiophobia) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Psychosocial functioning (screening for anxiety, depression and somatisation by relevant subscales from Symptom Checklist,SCL-90) [ Time Frame: 3 and 12 months after visit to emergency room ]
- Number of sick days (days off work due to illness) retrieved from Danish public registry (the DREAM database) [ Time Frame: 12 month period after visit to emergency room ]
- Health care use retrieved from The National Patient Register and the National Health Service Register (consultations with GPs, specialists, physiotherapists, dentists, emergency services) and The Danish Medicine Agency (medicine consumption) [ Time Frame: 12 month period after visit to emergency room ]
- Intensity of neck pain (NRS 0-10) [ Time Frame: 12 months after visit to emergency room ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699334
|Contact: Majbritt m Pedersen, MScemail@example.com|
|Contact: Lisbeth Frostholmfirstname.lastname@example.org|
|The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Majbritt M Pedersen, MSc +4578464310 email@example.com|
|Contact: Lisbeth Frostholm, MSc, PhD +4578464310 firstname.lastname@example.org|
|Principal Investigator: Per Fink, DMSc, PhD|
|Principal Investigator:||Per Fink, DMSc||University of Aarhus|