Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/09/2005
Date assigned
15/09/2005
Last edited
14/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kim Burton

ORCID ID

Contact details

30 Queen Street
Huddersfield
HD1 2SP
United Kingdom
-
kim@spineresearch.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of printed patient information for whiplash patients – is more better?

Acronym

WAD-ED

Study hypothesis

When compared with the control (limited information/advice on a small folded card), the experimental intervention (comprehensive evidence-based information/advice in a 28-page booklet) will improve beliefs about whiplash associated disorder and its consequences, and will increase the proportion of individuals who are self-managing by 3-months post-injury.

Ethics approval

Added 09/10/09: Received from the National Research Ethics Service (NRES), Airedale Research Ethics Committee (REC)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, contact kim@spineresearch.org.uk to request a patient information sheet

Condition

Whiplash associated disorders

Intervention

1. Evidence-based patient educational booklet (The Whiplash Book).
2. Small folded card giving llimited information

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Self-management of the whiplash associated disorder (i.e. the participant has ceased treatment and feels confident to self-manage their WAD without recourse to further healthcare), a dichotomous outcome measured by a structured questionnaire.

Secondary outcome measures

1. Beliefs
2. Disability
3. Pain

Overall trial start date

01/10/2005

Overall trial end date

01/10/2012

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Adults attending emergency departments following involvement as a vehicle occupant in a road traffic accident resulting in whiplash associated disorder of Quebec Grade 0 to III. 2. Good understanding of English.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

254

Participant exclusion criteria

1. Serious spinal pathology, including whiplash injury of Quebec Grade IV.
2. Any clinical conditions (mental or physical) or accident-related injuries that render participation inappropriate.

Recruitment start date

01/10/2005

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

30 Queen Street
Huddersfield
HD1 2SP
United Kingdom

Sponsor information

Organisation

University of Huddersfield (UK)

Sponsor details

Queensgate
Huddersfield
HD1 2SP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Huddersfield (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/06/2016: Added trial abandoned due to lack of funding 24/05/2016: No publications found, verifying study status with principal investigator