BackActive: exposure in vivo in chronic low back pain patients

ISRCTN	ISRCTN88087718
DOI	https://doi.org/10.1186/ISRCTN88087718
Protocol serial number	NTR417; Project number ZonMw 1436.0002
Sponsor	University Maastricht (UM) (Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Maaike Leeuw
Scientific

University Maastricht
Department of Medical Clinical and Experimental Psychology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3881600
Email	m.leeuw@dmkep.unimaas.nl

Primary study design	Interventional
Study design	Multicentre randomised single-blind active-controlled parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Physical activity level
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	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

University Maastricht

Maastricht
6200 MD
Netherlands

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

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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes