NCT03040245

Brief Summary

Whiplash trauma and the resulting whiplash associated disorders have been the subject of much attention in the scientific literature and remain a major public health problem. The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain, as well as visual impairment. It is not unusual for neck pain to become chronic, and when this occurs, there may be serious consequences on a social, professional and financial level. Even though the role of the initial episode should not be ignored, progression to chronic pain is probably multifactorial and, like non-specific low back pain, psycho-social factors, and in particular patient fears and belief, seem to play a relevant role, as do environmental factors. The professional consensus is that it is useful to provide targeted information at an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A preliminary study enabled the investigators to validate a French version of an information booklet that draws on validated data from evidence-based medicine. The booklet was "Le guide du coup de fouet cervical," the French version of The Whiplash Book. This study showed that fears and beliefs were considerably high in a population without neck problems who were working in hospitals. It also revealed that simply providing information could help lessen them. Management following whiplash injury can make use of the recommendations as published in the literature. Healthcare professionals must reassure and educate their patients that post-traumatic pain is normal, and that they need to remain active and maintain physical activity in order to improve their prognosis. Only very few studies have evaluated the adherence of physicians or healthcare professionals to the guidelines and to ways of changing their approach to treatment. The main aim of this study was to determine what fears and beliefs physicians have about the consequences of whiplash. The secondary aim was to measure the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 13, 2017

Last Update Submit

February 1, 2017

Conditions

Keywords

Emergency physicianWhiplash BookWhiplash traumaFearsBeliefs

Outcome Measures

Primary Outcomes (2)

  • assessment of fears and beliefs in the sample of physicians tested using questionnaire WBQ (whiplash belief questionnaire)

    For each statement, the physician must express his or her level of agreement or disagreement, with a score that varies from 9 to 45. The higher the score, the stronger the beliefs

    48 hours after reading the information booklet

  • assessment of fears and beliefs in the sample of physicians tested using the FABQ (Fear Avoidance Belief questionnaire)

    The FABQ (Fear Avoidance Belief questionnaire) comprises two independent scales: the physical activity FABQ and work FABQ

    48 hours after reading the information booklet

Secondary Outcomes (2)

  • Measurement of the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.

    10 days for control group or minimum 48 hours after reading the information booklet for interventional group

  • Non-pharmacological management of a whiplash injury

    10 days for control group or minimum 48 hours after reading the information booklet for interventional group

Study Arms (2)

intervention group

The intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet

Behavioral: Whiplash book

control group

The same items were included as in the initial folder, with an additional questionnaire enabling the intervention group to qualitatively assess the information booklet. If there was no response, reminders were sent by email, then by telephone, and lastly by post.

Behavioral: Whiplash book

Interventions

Whiplash bookBEHAVIORAL
control groupintervention group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

emergency physicians

You may qualify if:

  • \- Both sexes
  • Emergency medicine doctors
  • Doctors has given its consent to participate in the study

You may not qualify if:

  • no criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Emmanuel COUDEYRE

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 2, 2017

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations