BackActive: exposure in vivo in chronic low back pain patients
| ISRCTN | ISRCTN88087718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88087718 |
| Secondary identifying numbers | NTR417; Project number ZonMw 1436.0002 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 16/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Maaike Leeuw
Scientific
Scientific
University Maastricht
Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3881600 |
|---|---|
| m.leeuw@dmkep.unimaas.nl |
Study information
| Study design | Multicentre randomised single-blind active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| 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 | BackActive: exposure in vivo in chronic low back pain patients |
| Study acronym | BackActive |
| Study objectives | It is hypothesized that in chronic low back pain patients with fear of movement/(re)injury, exposure in vivo will be more effective in reducing functional disability levels than the usual graded activity treatment. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | Participants are randomly assigned to either exposure in vivo or behavioural graded activity. Through exposure in vivo, participants are motivated to perform activities, through which fear of movement/(re)injury and functional disability are decreased. Graded activity gradually increase physical activity levels by means of positive reinforcement and time contingency principles. |
| Intervention type | Other |
| Primary outcome measure | To evaluate the (cost-)effectiveness of a graded exposure in vivo treatment as compared to behavioural graded activity in patients with chronic low back pain who report substantial pain-related fear. Primary outcome measures: functional disability, generic functional status |
| Secondary outcome measures | Physical activity level |
| Overall study start date | 01/09/2003 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 110 |
| Key inclusion criteria | 1. Non-specific low back pain 2. Duration of pain disability 3 months or more 3. Age between 18-65 years 4. Substantial pain-related fear (Tampa Scale for Kinesiophobia >33) |
| Key exclusion criteria | 1. No consent 2. Illiteracy 3. Pregnancy 4. Substance abuse 5. Involvement in any litigation concerning disability income 6. Specific medical disorders and cardiovascular diseases, preventing participation at physical exercise 7. Low back pain attributable to recognizable pathology (e.g. infection, tumor, osteoporosis, rheumatoid arthritis, fracture, or inflammatory process, prolapsed intervertebral disc) 8. Psychopathology: pretest criteria applied to a standardized test, the SCL-90 and Beck Depression Inventory 9. Patients with restricted disability due to their back pain (Roland Disability Questionnaire score <4) |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (Netherlands)
University/education
University/education
Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
"ROR" |
https://ror.org/02jz4aj89 |
|---|
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
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? |
|---|---|---|---|---|---|
| Results article | results | 15/08/2008 | Yes | No | |
| Results article | results | 14/12/2015 | Yes | No |
