NCT01699334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

September 26, 2019

Status Verified

January 1, 2019

Enrollment Period

5.2 years

First QC Date

September 26, 2012

Last Update Submit

September 25, 2019

Conditions

Keywords

Whiplash injuriespatient educationillness perceptionsRCTmotor vehicle accidents

Outcome Measures

Primary Outcomes (1)

  • Intensity of neck pain

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

    3 months after visit to emergency room

Secondary Outcomes (9)

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

    3 and 12 months after visit to emergency room

  • Self-rated physical level of functioning (SF-36)

    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

  • +4 more secondary outcomes

Study Arms (2)

Psychoeducational video

EXPERIMENTAL
Behavioral: Psychoeducational video

Relaxation video

ACTIVE COMPARATOR
Other: Relaxation video

Interventions

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.

Psychoeducational 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.

Relaxation video

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 16103847BACKGROUND
  • 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.

    PMID: 16816758BACKGROUND
  • 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.

    PMID: 18820955BACKGROUND
  • 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.

    PMID: 19683817BACKGROUND
  • 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.

    PMID: 10421720BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Study Officials

  • Per Fink, DMSc

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2017

Study Completion

May 1, 2019

Last Updated

September 26, 2019

Record last verified: 2019-01

Locations