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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02570659
Other study ID # Erics Whiplash RCT
Secondary ID
Status Recruiting
Phase N/A
First received October 1, 2015
Last updated November 16, 2017
Start date October 2015
Est. completion date June 1, 2018

Study information

Verified date November 2017
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Knowledge of the swedish language

- Traffic injury with neck pain

Exclusion Criteria:

- Fractures

- In house care needed

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Information Video
A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise

Locations

Country Name City State
Sweden Eric Rydman Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Self reported pain the last three days (NRS) 6 months
Secondary Whiplash Disability Questionnaire (WDQ) 6 months
Secondary SF-12 Health related quality of life 6 months
See also
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