Effectiveness of an Educational Video Following Acute Whiplash Trauma
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Purpose
The purpose of this study is to examine the effect of an educational video on intensity of neck pain, disability, illness perceptions and work ability following acute whiplash trauma caused by motor vehicle accidents.
| Condition | Intervention |
|---|---|
|
Whiplash Injuries |
Behavioral: Psychoeducational video Other: Relaxation video |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial |
- Intensity of neck pain [ Time Frame: 3 months after visit to emergency room ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Self-rated physical level of functioning (SF-36) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
- Self-rated neck disability (Copenhagen Neck Functional Disability Scale) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
- Illness perceptions (The Brief Illness Perceptions Questionnaire) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
- Pain-related fear of movement (The Tampa Scale for Kinesiophobia) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Intensity of neck pain (NRS 0-10) [ Time Frame: 12 months after visit to emergency room ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Involved in a motor vehicle accident (as a passenger or driver of the vehicle)
- Subjective neck complaints (neck pain, headache or reduced range of motion)
- Treatment in emergency room within 72 hours of accident
- Diagnosed with a distortion of the neck (ICD-10 S13.4)
- No other major injuries
- Age 18-60 years
- Able
Exclusion Criteria:
- Fracture or dislocation
- Head trauma (loss of consciousness, concussion)
- Substance abuse (narcotics, alcohol, medicine)
- Severe acute psychiatric disorder, previous episodes of psychosis or if the patient is suicidal
- Dementia, mental retardation
- Active systemic disease (cancer, rheumatoid arthritis, neurological disorders)
- Lack of informed consent
Contacts and Locations| Contact: Majbritt m Pedersen, MSc | +4578464310 | majbrpde@rm.dk |
| Contact: Lisbeth Frostholm | +4578464310 | lisbfros@rm.dk |
| Denmark | |
| The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Majbritt M Pedersen, MSc +4578464310 majbrpde@rm.dk | |
| Contact: Lisbeth Frostholm, MSc, PhD +4578464310 lisbfros@rm.dk | |
| Principal Investigator: Per Fink, DMSc, PhD | |
| Principal Investigator: | Per Fink, DMSc | University of Aarhus |
More Information
Publications:
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01699334 History of Changes |
| Other Study ID Numbers: | 8011-170712 |
| Study First Received: | September 26, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Whiplash injuries patient education illness perceptions RCT motor vehicle accidents |
Additional relevant MeSH terms:
|
Whiplash Injuries Neck Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013