Contact information
Type
Scientific
Primary contact
Dr Maaike Leeuw
ORCID ID
Contact details
University Maastricht
Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881600
m.leeuw@dmkep.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR417; Project number ZonMw 1436.0002
Study information
Scientific title
BackActive: exposure in vivo in chronic low back pain patients
Acronym
BackActive
Study 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.
Ethics approval
Received from local medical ethics committee
Study design
Multicentre randomised single-blind active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2003
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant 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)
Recruitment start date
01/09/2003
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
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
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18242858
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26651828
Publication citations
-
Results
Leeuw M, Goossens ME, van Breukelen GJ, de Jong JR, Heuts PH, Smeets RJ, Köke AJ, Vlaeyen JW, Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial., Pain, 2008, 138, 1, 192-207, doi: 10.1016/j.pain.2007.12.009.
-
Results
Goossens ME, de Kinderen RJ, Leeuw M, de Jong JR, Ruijgrok J, Evers SM, Vlaeyen JW, Is exposure in vivo cost-effective for chronic low back pain? A trial-based economic evaluation, BMC Health Serv Res, 2015, 15, 1, 549.