Choosing the most efficient and cost-effective treatment for acute whiplash associated disorders (WAD)

ISRCTN	ISRCTN61531337
DOI	https://doi.org/10.1186/ISRCTN61531337
Protocol serial number	N/A
Sponsor	The Swedish Research Council (Sweden)
Funders	The Swedish Research Council (Sweden), Uppsala University (Sweden) - Faculty of Medicine

Submission date: 03/02/2009
Registration date: 27/03/2009
Last edited: 30/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anne Söderlund
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised prospective experimental three-group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Research Ethics Committee at Uppsala University, Uppsala, Sweden gave approval in May 2005 (ref: 01-229)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	180
Key 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
Key exclusion criteria	1. Prior neck injury 2. Other ongoing chronic pain problems 3. Ongoing treatment for pain or pain related symptoms
Date of first enrolment	01/11/2006
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Sweden

Study participating centre

Department of Physiotherapy

Västerås
S-72126
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	22/07/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes