|- candidate number||1714|
|- NTR Number||NTR417|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||21-sep-2005|
|- Secondary IDs||1436.0002 Projectnummer ZonMw |
|- Public Title||BackActive: Exposure in vivo in chronic low back pain patients.|
|- Scientific Title||The cost-effectiveness of a customized cognitive-behavioral exposure in vivo treatment in patients with chronic low back pain reporting fear of movement/(re)injury.
A randomized clinical trial.|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP)|
|- Inclusion criteria||Criteria for acceptance in the study are:|
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).
|- Exclusion criteria||Exclusion criteria are: |
1. No consent;
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).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2003|
|- planned closingdate||1-sep-2007|
|- Target number of participants||110|
|- Interventions||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. |
|- Primary outcome||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||Physical activity level.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. Maaike Leeuw|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Johan W.S. Vlaeyen|
|- Sponsor/Initiator ||University Maastricht (UM), Department of Medical Clinical and Experimental Psychology (DMKEP)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Fear of movement/(re)injury is an important determinant in the development and maintenance of chronic low back pain (CLBP). CLBP patients with substantial fear of movement/(re)injury might benefit from exposure in vivo treatment that aims to increase physical activity level by means of decreasing fear of movement/(re)injury. During exposure in vivo patients have to perform activities that are considered harmful to the back. Both through the use of exposure in vivo and behavioural experiments fear is reduced, while beliefs about the harmful consequences of activities are disconfirmed.
Patients are randomly assigned to either exposure in vivo or graded activity. Measurements take place twice before treatment, directly after treatment, and 6 and 12 months after treatment. During treatment daily measurements are gathered. |
|- Main changes (audit trail)|
|- RECORD||21-sep-2005 - 5-jan-2010|