Clinical Trial: Effectiveness of an Educational Video Following Acute Whiplash Trauma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial

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 Summary:

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
Sponsor: University of Aarhus

Current 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: September 26, 2012
Date Started: October 2012
Date Completion: May 2018
Last Updated: June 10, 2016
Last Verified: June 2016