Whiplash InjuriesNCT01699334
Effectiveness of an Educational Video Following Acute Whiplash Trauma
A study testing Psychoeducational video and Relaxation video in people with Whiplash Injuries, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Psychoeducational video and Relaxation video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Whiplash Injuries
- Being tested
- Psychoeducational video, Relaxation video
- Keywords
- Whiplash injuries, patient education, illness perceptions, RCT, motor vehicle accidents
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational videoBehavioural
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.
Relaxation videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational video | Experimental | Not described Receives: Behavioral: Psychoeducational video |
| Relaxation video | Active comparator | Not described Receives: Other: Relaxation video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of neck pain
11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)
Measured: 3 months after visit to emergency room
Secondary outcomes (9)
Self-rated level of recovery (Patient Global Impression of Change)
Measured: 3 and 12 months after visit to emergency room
Self-rated physical level of functioning (SF-36)
Measured: 3 and 12 months after visit to emergency room
Self-rated neck disability (Copenhagen Neck Functional Disability Scale)
Measured: 3 and 12 months after visit to emergency room
Illness perceptions (The Brief Illness Perceptions Questionnaire)
Measured: 3 and 12 months after visit to emergency room
Pain-related fear of movement (The Tampa Scale for Kinesiophobia)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 12 month period after visit to emergency room
Intensity of neck pain (NRS 0-10)
Measured: 12 months after visit to emergency room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Per Fink, DMSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699334
- Sponsor's protocol ID
- 8011-170712
- Status last verified
- Jan 2019
- First submitted
- 26 Sep 2012
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16103847Oliveira 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.
PubMed 16816758Whiplash 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.
PubMed 18820955Leth-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.
PubMed 19683817Holm 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.
PubMed 10421720
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01699334
- Acronym / sponsor ID
- 8011-170712
- Conditions
- Whiplash Injuries
- Keywords
- Whiplash injuries, patient education, illness perceptions, RCT, motor vehicle accidents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational video | Experimental | Behavioral: Psychoeducational video |
| Relaxation video | Active comparator | Other: Relaxation video |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational videoThe 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. | Behavioural | Psychoeducational video |
| Relaxation videoThe 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. | Other | Relaxation video |
Primary outcome
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)
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 16103847Brison 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.
- Background: PubMed 16816758Oliveira 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.
- Background: PubMed 18820955Whiplash 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.
- Background: PubMed 19683817Leth-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.
- Background: PubMed 10421720Holm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Fink, DMSc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational video and Relaxation video in people with Whiplash Injuries, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of neck pain (time frame: 3 months after visit to emergency room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699334, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.