Effectiveness of an Educational Video Following Acute Whiplash Trauma

September 25, 2019 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

269

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months after visit to emergency room

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-rated level of recovery (Patient Global Impression of Change)
Time Frame: 3 and 12 months after visit to emergency room
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
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
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
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
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
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
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
12 month period after visit to emergency room
Intensity of neck pain (NRS 0-10)
Time Frame: 12 months after visit to emergency room
12 months after visit to emergency room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Per Fink, DMSc, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

May 1, 2019

Study Registration Dates

First Submitted

September 26, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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