Choosing the most efficient and cost-effective treatment for acute whiplash associated disorders (WAD)
| ISRCTN | ISRCTN61531337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61531337 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Physiotherapy
School of Health, Care and Social Welfare
Malardalen University
BOX 1020
Västerås
S-72126
Sweden
Study information
| Study design | Randomised prospective experimental three-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/11/2006 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 participants |
| 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
S-72126
Sweden
Sponsor information
The Swedish Research Council (Sweden)
Research council
Research council
Klarabergsviadukten 82
Stockholm
S-10378
Sweden
| Website | http://www.vr.se/ |
|---|---|
"ROR" |
https://ror.org/03zttf063 |
Funders
Funder type
Research council
The Swedish Research Council (Sweden)
No information available
Uppsala University (Sweden) - Faculty of Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
