Whiplash TraumaWHIPLASHNCT03040245
Measuring the Impact of the French Version of the Whiplash Book
An observational study of Whiplash Trauma, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Trauma
- What is being tested?
- Whiplash book
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: emergency physicians
Who may be able to join
- - Both sexes
- Emergency medicine doctors
- Doctors has given its consent to participate in the study
Who cannot join
- no criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring the Impact of the French Version of the Whiplash Book on Both Treatment Approach and Fears and Beliefs Among Emergency Physicians
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.
Read more
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.
Read the detailed description
Once each of the department heads and the different physicians concerned had given their agreement to take part in the study, an initial questionnaire folder (containing the WBQ and FABQ) was sent by email and by post to each of the physicians drawn by randomization. Upon inclusion, demographic data was collected from the physicians (gender, age, place of practice, and length of time in practice), as well as any personal or family history of neck pain or whiplash. The physicians were also asked how often they encountered cases of whiplash.
Information about knowledge of whiplash injury was also sought. This included continuing medical training or recent reading (within the previous 3 years), and in particular knowledge of the different severity grades established by the Quebec Task Force classification, the radiologic recommendations of the Canadian C-Spine Rule, and lastly the latest HAS recommendation on physical therapy in post-whiplash neck pain.
Once the first questionnaire folder had been completed, a second folder was then sent to all physicians participating in the study. The intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet.
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.
- Conditions
- Whiplash Trauma
- Being tested
- Whiplash book
- Keywords
- Emergency physician, Whiplash Book, Whiplash trauma, Fears, Beliefs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whiplash bookBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Whiplash book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
Non-pharmacological management of a whiplash injury
Non-pharmacological management of a whiplash injury estimated by :
- Prescription of necklace (yes/no (%)) If yes, duration of prescription
- Prescription of physiotherapy sessions (%)
- Work cessation yes/no (%)
Measured: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJun 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- CH Aurillac, Jacques Lacarin Hospital Center, CH Moulins, CH Montluçon, CH Issoire, CH Thiers, CH Ambert
- Responsible party
- Sponsor
- Investigators
- Emmanuel COUDEYRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040245
- Sponsor's protocol ID
- CHU 298
- Acronym
- WHIPLASH
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of the French Version of the Whiplash Book on Both Treatment Approach and Fears and Beliefs Among Emergency Physicians
- ClinicalTrials.gov ID
- NCT03040245
- Acronym / sponsor ID
- WHIPLASH / CHU 298
- Conditions
- Whiplash Trauma
- Keywords
- Emergency physician, Whiplash Book, Whiplash trauma, Fears, Beliefs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- CH Aurillac, Jacques Lacarin Hospital Center, CH Moulins, CH Montluçon, CH Issoire, CH Thiers, CH Ambert
- Study start
- Jun 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Once each of the department heads and the different physicians concerned had given their agreement to take part in the study, an initial questionnaire folder (containing the WBQ and FABQ) was sent by email and by post to each of the physicians drawn by randomization. Upon inclusion, demographic data was collected from the physicians (gender, age, place of practice, and length of time in practice), as well as any personal or family history of neck pain or whiplash. The physicians were also asked how often they encountered cases of whiplash.
Information about knowledge of whiplash injury was also sought. This included continuing medical training or recent reading (within the previous 3 years), and in particular knowledge of the different severity grades established by the Quebec Task Force classification, the radiologic recommendations of the Canadian C-Spine Rule, and lastly the latest HAS recommendation on physical therapy in post-whiplash neck pain.
Once the first questionnaire folder had been completed, a second folder was then sent to all physicians participating in the study. The intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Behavioral: Whiplash bookThe intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet |
| control group | – | Behavioral: Whiplash bookThe 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- emergency physicians
Key inclusion criteria (3 listed)
- - Both sexes
- Emergency medicine doctors
- Doctors has given its consent to participate in the study
Key exclusion criteria (1 listed)
- no criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whiplash book | Behavioural | control group, intervention group |
Primary outcome
assessment of fears and beliefs in the sample of physicians tested using questionnaire WBQ (whiplash belief questionnaire)
Time frame: 48 hours after reading the information booklet
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
assessment of fears and beliefs in the sample of physicians tested using the FABQ (Fear Avoidance Belief questionnaire)
Time frame: 48 hours after reading the information booklet
The FABQ (Fear Avoidance Belief questionnaire) comprises two independent scales: the physical activity FABQ and work FABQ
2 secondary outcomes
Measurement of the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.
Time frame: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
Non-pharmacological management of a whiplash injury
Time frame: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
Related trials for Whiplash Trauma
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Virtual Reality Rehabilitation in Neck Pain Subjects
Neck Pain, Chronic Pain
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
Whiplash Injuries
Recruiting
Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
Cervicogenic Headache, Whiplash Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel COUDEYRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whiplash Trauma, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of fears and beliefs in the sample of physicians tested using questionnaire WBQ (whiplash belief questionnaire) (time frame: 48 hours after reading the information booklet). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.