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临床试验/NCT01699334
NCT01699334已完成不适用

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

University of Aarhus2 个研究点 分布在 1 个国家目标入组 269 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
269
试验地点
2
主要终点
Intensity of neck pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Psychoeducational video

Experimental

干预措施: Psychoeducational video (Behavioral)

Relaxation video

Active Comparator

干预措施: Relaxation video (Other)

结局指标

主要结局

Intensity of neck pain

时间窗: 3 months after visit to emergency room

11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)

次要结局

  • Self-rated physical level of functioning (SF-36)(3 and 12 months after visit to emergency room)
  • Self-rated level of recovery (Patient Global Impression of Change)(3 and 12 months after visit to emergency room)
  • Self-rated neck disability (Copenhagen Neck Functional Disability Scale)(3 and 12 months after visit to emergency room)
  • Illness perceptions (The Brief Illness Perceptions Questionnaire)(3 and 12 months after visit to emergency room)
  • Pain-related fear of movement (The Tampa Scale for Kinesiophobia)(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)(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)(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)(12 month period after visit to emergency room)
  • Intensity of neck pain (NRS 0-10)(12 months after visit to emergency room)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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