Trial record 5 of 15 for:    Open Studies | "Neck Injuries"

Effectiveness of an Educational Video Following Acute Whiplash Trauma

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01699334
First received: September 26, 2012
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Whiplash Injuries
Behavioral: Psychoeducational video
Other: Relaxation video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Intensity of neck pain [ Time Frame: 3 months after visit to emergency room ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
  • Self-rated physical level of functioning (SF-36) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
  • Self-rated neck disability (Copenhagen Neck Functional Disability Scale) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
  • Illness perceptions (The Brief Illness Perceptions Questionnaire) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
  • Pain-related fear of movement (The Tampa Scale for Kinesiophobia) [ Time Frame: 3 and 12 months after visit to emergency room ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Intensity of neck pain (NRS 0-10) [ Time Frame: 12 months after visit to emergency room ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychoeducational video Behavioral: 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 Other: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699334

Contacts
Contact: Majbritt m Pedersen, MSc +4578464310 majbrpde@rm.dk
Contact: Lisbeth Frostholm +4578464310 lisbfros@rm.dk

Locations
Denmark
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Majbritt M Pedersen, MSc    +4578464310    majbrpde@rm.dk   
Contact: Lisbeth Frostholm, MSc, PhD    +4578464310    lisbfros@rm.dk   
Principal Investigator: Per Fink, DMSc, PhD         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Per Fink, DMSc University of Aarhus
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01699334     History of Changes
Other Study ID Numbers: 8011-170712
Study First Received: September 26, 2012
Last Updated: January 20, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Whiplash injuries
patient education
illness perceptions
RCT
motor vehicle accidents

Additional relevant MeSH terms:
Whiplash Injuries
Wounds and Injuries
Neck Injuries

ClinicalTrials.gov processed this record on July 23, 2014