Condition category
Musculoskeletal Diseases
Date applied
17/06/2015
Date assigned
18/06/2015
Last edited
29/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Whiplash associated disorder (WAD) is a neck injury usually caused by a road traffic accident. More people are affected by whiplash each year and it can lead to pain and disability. Therefore, it is important for a physiotherapist to prevent the condition becoming chronic (i.e. persisting over a longer period) by using effective management in the acute stage (i.e. just after the injury occurs). The evidence so far suggests that a combination of active and behavioural treatment programme when the patient is still acute may be a useful strategy to manage WAD. We have developed an active behavioural physiotherapy treatment programme using international experts that we plan to use in a large clinical trial to see if it works. The aim of this study, therefore, is to evaluate procedures, feasibility and acceptability of the active behavioural physiotherapy treatment for acute WAD.

Who can participate?
Adults between 18-70 who have neck problems that were caused by a road traffic accident within the last four weeks. Their neck problems are classified as whiplash associated disorder (WAD) II.

What does the study involve?
There are two phases to this trial. In phase 1 (pilot and feasibility trial), six private physiotherapy clinics in West Midlands, UK are randomly allocated into one of two groups. Participants attending clinics in group 1 (control) are given standard physiotherapy treatments. Participants attending clinics in group 2 (intervention) are given the active behavioural physiotherapy intervention. This phase of the study tests the procedures used and feasibility of the intervention in managing acute WADII in preparation for a larger study. In phase 2, the acceptability of the developed intervention is explored. All physiotherapists in the intervention group are interviewed by a researcher to evaluate the acceptability of the active behavioural physiotherapy intervention for acute WADII management compared with standard physiotherapy. Around six to eight participants in the intervention group are invited to participate in a focus group to evaluate the acceptability of the active behavioural physiotherapy intervention to the patients.

What are the possible benefits and risks of participating?
Participants will receive physiotherapy treatment as part of this study. Some participants will receive current standard care and others will receive an active behavioural physiotherapy treatment. We are interested in whether one treatment is better than the other to improve management of patients with WAD and to prevent chronic problems. If we can prevent chronic problems, patients can return to their quality of life, direct and indirect medical costs will be reduced. No serious adverse event has been reported in physiotherapy management for WADs.

Where is the study run from?
Six private physiotherapy clinics, West Midlands (UK)

When is the study starting and how long is it expected to run for?
October 2013 to December 2015

Who is funding the study?
The Royal Thai Government.

Who is the main contact?
Mr Taweewat Wiangkham
txw214@bham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Taweewat Wiangkham

ORCID ID

http://orcid.org/0000-0003-4115-704X

Contact details

29 Woodleigh Avenue
Birmingham
B17 0NW
United Kingdom

Type

Scientific

Additional contact

Mr Taweewat Wiangkham

ORCID ID

http://orcid.org/0000-0003-4115-704X

Contact details

School of Sport
Exercise and Rehabilitation Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
07474410449
txw214@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acute Whiplash Injury Study (AWIS): a cluster randomised pilot and feasibility trial of an active behavioural physiotherapy intervention for acute Whiplash Associated Disorder (WAD) II management in an insurance private setting

Acronym

AWIS

Study hypothesis

To evaluate procedures, feasibility and acceptability of the active behavioural physiotherapy intervention in managing acute WADII within the UK insurance/private sector to inform the design of a future definitive (phase III) trial

Ethics approval

NHS ethical approval and R&D approval is not required as the trial sits outside of the UK national health system. The insurance / private clinics do not require any other regulatory approval. Support for the trial is in place by the insurance / private clinics and the insurance companies. Ethical approval will be obtained from the University of Birmingham’s Ethics Committee.

Study design

A pilot and feasibility clinical trial of a prospective cluster randomised double blind parallel 2 arm design, with an embedded qualitative study to explore the acceptability of the developed intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Whiplash associated disorder (WAD)

Intervention

1. Standard physiotherapy intervention:
Each participant will attend a physiotherapy session lasting for 30 minutes once a week. Patients with acute whiplash associated disorder II (WADII) will be managed using the recommendation from clinical whiplash guidelines. Physiotherapy interventions such as manual therapy, exercise therapy and physical agents including a home programme of exercises will be considered to manage WADII patients depending on the individual physiotherapist’s clinical reasoning for the individual patient. The treating physiotherapists will select appropriate interventions based on examination findings and scientifically clinical reasoning. Physiotherapists in this treatment arm will be recalled regarding the current standard physiotherapy intervention which is comes from clinical guidelines. A day in June will be established for the recalled meeting prior to recruitment of participants.
2. Active behavioural physiotherapy intervention:
The specific detail of this intervention including the underlying principles and the components was developed by whiplash experts across the world in the previous study: “The development of an active behavioural physiotherapy intervention for acute WADII management” using a modified Delphi method. This study has been approved by the University of Birmingham’s Ethical Committee (ERN_ 14-1339) before piloting, recruiting participants and implementing the modified Delphi study.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Neck Disability Index (NDI)

Secondary outcome measures

1. Visual Analogue Scale (VAS) for pain intensity
2. Cervical Range of Motion (CROM)
3. Pressure Pain Threshold (PPT)
4. Impact of Events Scale (IES)
5. Fear Avoidance Beliefs Questionnaire (FABQ)
6. Quality of Life (EQ5D-5L)

Overall trial start date

01/01/2015

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Participants:
1. aged from 18 to 70 years old
2. presenting with WAD grade II from a road traffic accident within the previous four weeks

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Signs and symptoms of upper cervical instability or cervical artery dysfunction
2. Suspected serious spinal pathology
3. Open wounds
4. Active inflammatory arthritis
5. Tumours
6. Infection of the skin and soft tissue
7. Bleeding disorders or using anti-coagulant medication
8. Any current or previous treatment from any other third party or presenting with any serious injuries from other areas of the body resulting from the accident
9. History of cervical surgery,previously symptomatic degenerative diseases of cervical spine within 6 months before road traffic accident
10. Previous history of whiplash or other neck pain
11. Alcohol abuse
12. Dementia
13. Serious mental diseases
14. Psychiatric diseases
15. Non-native English speaking

Recruitment start date

06/11/2015

Recruitment end date

02/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Junction 1 Fitness
High Street West Bromwich
West Midlands
B70 6JT
United Kingdom

Trial participating centre

Bannatyne's Health Club
3 Brunswick Arcade Brindley Place
Birmingham
B1 2JF
United Kingdom

Trial participating centre

Spirit Health Club (Holiday Inn Birmingham M6 Jct 7)
Chapel Lane Great Barr
Birmingham
B43 7BG
United Kingdom

Trial participating centre

Moseley
1 Salisbury Road Moseley
Birmingham
B13 8JS
United Kingdom

Trial participating centre

Bannatyne's Health Club
Princess Alice Drive Sutton Coldfield
Birmingham
B73 6RB
United Kingdom

Trial participating centre

Fitness First
Ulleries Road Solihull
West Midlands
B92 8DS
United Kingdom

Sponsor information

Organisation

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Ministry of Science and Technology of Thailand under the Royal Thai Government

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to submit our protocol to a journal for protocol publication in July 2015. The target journal for protocol publication is BMJ Open. We also plan to submit in January 2016.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/27412105

Publication citations

Additional files

Editorial Notes

29/07/2016: The overall trial end date has been updated from 31/10/2016 to 01/10/2016 and the recruitment end date has been updated from 01/06/2016 to 02/07/2016. In addition, the participant information sheet has been added. 21/07/2016: Publication reference added. 12/01/2016: The following changes were made to the trial record: 1. The overall trial start date was changed from 15/10/2013 to 01/01/2015. 2. The overall trial end date was changed from 31/12/2015 to 31/10/2016. 3. The recruitment start date was changed from 20/07/2015 to 06/11/2015. 4. The recruitment end date was changed from 30/09/2015 to 01/06/2016.