Effectiveness of an Educational Video Following Acute Whiplash Trauma
Primary Purpose
Whiplash Injuries
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Psychoeducational video
Relaxation video
Sponsored by
About this trial
This is an interventional treatment trial for Whiplash Injuries focused on measuring Whiplash injuries, patient education, illness perceptions, RCT, motor vehicle accidents
Eligibility Criteria
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
Sites / Locations
- The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psychoeducational video
Relaxation video
Arm Description
Outcomes
Primary Outcome Measures
Intensity of neck pain
11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)
Secondary Outcome Measures
Self-rated level of recovery (Patient Global Impression of Change)
Self-rated physical level of functioning (SF-36)
Self-rated neck disability (Copenhagen Neck Functional Disability Scale)
Illness perceptions (The Brief Illness Perceptions Questionnaire)
Pain-related fear of movement (The Tampa Scale for Kinesiophobia)
Psychosocial functioning (screening for anxiety, depression and somatisation by relevant subscales from Symptom Checklist,SCL-90)
Number of sick days (days off work due to illness) retrieved from Danish public registry (the DREAM database)
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)
Intensity of neck pain (NRS 0-10)
Full Information
NCT ID
NCT01699334
First Posted
September 26, 2012
Last Updated
September 25, 2019
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01699334
Brief Title
Effectiveness of an Educational Video Following Acute Whiplash Trauma
Official Title
Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
Whiplash injuries, patient education, illness perceptions, RCT, motor vehicle accidents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducational video
Arm Type
Experimental
Arm Title
Relaxation video
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Relaxation video
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of neck pain
Description
11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)
Time Frame
3 months after visit to emergency room
Secondary Outcome Measure Information:
Title
Self-rated level of recovery (Patient Global Impression of Change)
Time Frame
3 and 12 months after visit to emergency room
Title
Self-rated physical level of functioning (SF-36)
Time Frame
3 and 12 months after visit to emergency room
Title
Self-rated neck disability (Copenhagen Neck Functional Disability Scale)
Time Frame
3 and 12 months after visit to emergency room
Title
Illness perceptions (The Brief Illness Perceptions Questionnaire)
Time Frame
3 and 12 months after visit to emergency room
Title
Pain-related fear of movement (The Tampa Scale for Kinesiophobia)
Time Frame
3 and 12 months after visit to emergency room
Title
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
Title
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
Title
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
Title
Intensity of neck pain (NRS 0-10)
Time Frame
12 months after visit to emergency room
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Fink, DMSc
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
16103847
Citation
Brison RJ, Hartling L, Dostaler S, Leger A, Rowe BH, Stiell I, Pickett W. A randomized controlled trial of an educational intervention to prevent the chronic pain of whiplash associated disorders following rear-end motor vehicle collisions. Spine (Phila Pa 1976). 2005 Aug 15;30(16):1799-807. doi: 10.1097/01.brs.0000174115.58954.17.
Results Reference
background
PubMed Identifier
16816758
Citation
Oliveira A, Gevirtz R, Hubbard D. A psycho-educational video used in the emergency department provides effective treatment for whiplash injuries. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1652-7. doi: 10.1097/01.brs.0000224172.45828.e3.
Results Reference
background
PubMed Identifier
18820955
Citation
Whiplash injuries: diagnosis and early management. The Swedish Society of Medicine and the Whiplash Commission Medical Task Force. Eur Spine J. 2008 Oct;17 Suppl 3(Suppl 3):355-358. doi: 10.1007/s00586-008-0767-x. No abstract available.
Results Reference
background
PubMed Identifier
19683817
Citation
Leth-Petersen S, Rotger GP. Long-term labour-market performance of whiplash claimants. J Health Econ. 2009 Sep;28(5):996-1011. doi: 10.1016/j.jhealeco.2009.06.013. Epub 2009 Jul 8.
Results Reference
background
PubMed Identifier
10421720
Citation
Holm L, Cassidy JD, Sjogren Y, Nygren A. Impairment and work disability due to whiplash injury following traffic collisions. An analysis of insurance material from the Swedish Road Traffic Injury Commission. Scand J Public Health. 1999 Jun;27(2):116-23. doi: 10.1080/140349499445301.
Results Reference
background
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Effectiveness of an Educational Video Following Acute Whiplash Trauma
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