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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

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 groups in NCT01699334
Study groupRoleWhat they receive
Psychoeducational videoExperimentalNot described
Receives: Behavioral: Psychoeducational video
Relaxation videoActive comparatorNot described
Receives: Other: Relaxation video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. Self-rated level of recovery (Patient Global Impression of Change)

    Measured: 3 and 12 months after visit to emergency room

  2. Self-rated physical level of functioning (SF-36)

    Measured: 3 and 12 months after visit to emergency room

  3. Self-rated neck disability (Copenhagen Neck Functional Disability Scale)

    Measured: 3 and 12 months after visit to emergency room

  4. Illness perceptions (The Brief Illness Perceptions Questionnaire)

    Measured: 3 and 12 months after visit to emergency room

  5. Pain-related fear of movement (The Tampa Scale for Kinesiophobia)

    Measured: 3 and 12 months after visit to emergency room

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted3 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2017
  4. Study completionMay 2019

Resources

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)
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 16103847
  • 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.

    PubMed 16816758
  • 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.

    PubMed 18820955
  • 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.

    PubMed 19683817
  • 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.

    PubMed 10421720

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.

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