Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/02/2009
Date assigned
27/03/2009
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively 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 Anne Söderlund

ORCID ID

Contact details

Department of Physiotherapy
School of Health
Care and Social Welfare
Malardalen University
BOX 1020
Västerås
S-72126
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised three-group study, internet-based, face-to-face based and standard-management after acute whiplash associated disorders (WAD): choosing the most efficient and cost-effective treatment

Acronym

Study hypothesis

The main purpose of this study is to try a new intervention strategy aimed to reduce the number of patients who have persistent problems after the whiplash injury. The goal is also to identify which of three different interventions that is most cost-effective for whiplash associated disorders (WAD) patients and the health care system. In this study we are controlling for two factors. First, the effect of behavioural medicine approach is evaluated. Second, the manner in which the treatment is administered, IT or face-to-face, is evaluated.

Ethics approval

Research Ethics Committee at Uppsala University, Uppsala, Sweden gave approval in May 2005 (ref: 01-229)

Study design

Randomised prospective experimental three-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute whiplash associated disorders

Intervention

Group 1: The new IT-based treatment (internet/e-mail) regimen for acute WAD patients, emphases self-monitoring and skills training, as well as discussions led by a therapist
Group 2: Face-to-face intervention involves groups of three to six patients led by therapists. The face-to-face program is planned to be similar to the IT-based treatment regimen described above, but differs in the way the treatment is administered.
Group 3: Standard care of these patients currently involves a visit to a physical therapist, which provides a home exercise program dealing with physical symptoms and advice of returning to normal activities as soon as possible. No further treatment is given except the home exercise program that all patients get at the emergency ward (standard care) before randomisation.

Both IT and face-to-face treatments:
Number of sessions: 7
Duration of sessions: 1 hour
Duration of treatment: about 7 - 9 weeks

Standard management:
1 hour only once.

Total duration of follow-up for all groups is 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Disability, measured with Pain Disability Index
2. Cost-effectiveness, evaluated with a cost-diary

Measured at pre-, post-treatment, 3, 6, 12, 24 months follow-ups.

Secondary outcome measures

1. The Patient Goal Priority Questionnaire (PGPQ)
2. Tampa Scale for Kinesiophopia
3. Pain Intensity Diary
4. Self-Efficacy Scale
5. Coping Strategies Questionnaire
6. 36-item short form health survey (SF-36)
7. Exercise diary

Measured at pre-, post-treatment, 3, 6, 12, 24 months follow-ups. QALYs are measured at 12 and 24 years follow-up.

Overall trial start date

01/11/2006

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years, either sex
2. Satisfactory Swedish language skills
3. Fulfill criteria for the diagnosis of WAD grade I and II
4. Ongoing pain in the neck due to the accident
5. Access to a computer

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180 participants

Participant exclusion criteria

1. Prior neck injury
2. Other ongoing chronic pain problems
3. Ongoing treatment for pain or pain related symptoms

Recruitment start date

01/11/2006

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Physiotherapy
Västerås
S-72126
Sweden

Sponsor information

Organisation

The Swedish Research Council (Sweden)

Sponsor details

Klarabergsviadukten 82
Stockholm
S-10378
Sweden

Sponsor type

Research council

Website

http://www.vr.se/

Funders

Funder type

Research council

Funder name

The Swedish Research Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Uppsala University (Sweden) - Faculty of Medicine

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

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19624833

Publication citations

  1. Protocol

    Söderlund A, Bring A, Asenlöf P, A three-group study, internet-based, face-to-face based and standard- management after acute whiplash associated disorders (WAD) - choosing the most efficient and cost-effective treatment: study protocol of a randomized controlled trial., BMC Musculoskelet Disord, 2009, 10, 90, doi: 10.1186/1471-2474-10-90.

Additional files

Editorial Notes