Whiplash SyndromeNCT02570659
Investigating the Effect of an Information Video for Neck Injuries in a Emergency Department Setting
A study testing Information Video in people with Whiplash Syndrome, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Whiplash Syndrome
- What is being tested?
- Information Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to 1 Jun 2018
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Knowledge of the swedish language
- Traffic injury with neck pain
Who cannot join
- Fractures
- In house care needed
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Eric Rydman
Stockholm
Eric Rydman, +46704331436
About this study
Official title: A Randomized Controlled Trial Evaluating the Effect of an Information Video in a Acute Whiplash Population
A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).
Read the detailed description
Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, <18<65 years of age and low knowledge of the Swedish language.
A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.
The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.
The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.
The primary outcome is level of pain (NRS)
- Conditions
- Whiplash Syndrome
- Being tested
- Information Video
- Keywords
- WAD, Whiplash, Information Video
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information VideoBehavioural
A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise
| Study group | Role | What they receive |
|---|---|---|
| Information Folder | No intervention | A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual) |
| Information Video | Experimental | A multiprofessional information video Receives: Behavioral: Information Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Self reported pain the last three days (NRS)
Measured: 6 months
Secondary outcomes (2)
Whiplash Disability Questionnaire (WDQ)
Measured: 6 months
SF-12
Health related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Rydman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570659
- Sponsor's protocol ID
- Erics Whiplash RCT
- Status last verified
- Nov 2017
- First submitted
- 1 Oct 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effect of an Information Video in a Acute Whiplash Population
- ClinicalTrials.gov ID
- NCT02570659
- Acronym / sponsor ID
- Erics Whiplash RCT
- Conditions
- Whiplash Syndrome
- Keywords
- WAD, Whiplash, Information Video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 7 Oct 2015 (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.
A randomized controlled trial (RCT) to investigate the effect of a information video, consisting of a multiprofessional team, on patients with acute Whiplash Associated Disorder (WAD).
Detailed description
Patients seeking medical care at Södersjukhuset Hospital, Sweden, after a motor vehicle accident resulting in neck trauma are offered to be included in the study. Inclusion criterias involve spine fractures, need for in house care, <18<65 years of age and low knowledge of the Swedish language.
A randomization is performed with two arms, one being "treatment as usual" i.e. an information folder with physiotherapeutic exercises, the other one being the Information Video.
The patients are contacted per telephone and a questionnaire with baseline data is sent via e-mail within a week after the accident. They also receive a link to the websites with the information.
The follow up time is 6 months and after that the patients receive a new questionnaire with questions regarding neck-specific status (WDQ), health related quality of life (SF-12) and pain.
The primary outcome is level of pain (NRS)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Folder | No intervention | –A folder with advise and exercises used by physiotherapeutic clinic of Södersjukhuset Hospital (Treatment as usual) |
| Information Video | Experimental | Behavioral: Information VideoA multiprofessional information video |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knowledge of the swedish language
- Traffic injury with neck pain
Key exclusion criteria (2 listed)
- Fractures
- In house care needed
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 |
|---|---|---|
| Information VideoA 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise | Behavioural | Information Video |
Primary outcome
Pain
Time frame: 6 months
Self reported pain the last three days (NRS)
2 secondary outcomes
Whiplash Disability Questionnaire (WDQ)
Time frame: 6 months
SF-12
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
Related trials for Whiplash Syndrome
Not yet recruiting
Effectiveness of Percutaneous Electrolysis and Dry Needling vs. Standard Therapy for Whiplash Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information Video in people with Whiplash Syndrome, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 6 months). 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 20 Nov 2017.