Cognitive-behavioural interventions have been shown to be effective in chronic low back pain (LBP).
An early intervention in patients with subacute low back pain (duration 4 to 12 weeks) may decrease
the risk of developing chronic disability and work loss. The objective of the proposed randomised
trial is to evaluate the (cost-)effectiveness of a cognitive-behavioural intervention by the general
practitioner (GP) in the prevention of chronic disability in LBP. Baseline assessment includes a
screening for psychosocial risk factors. Randomisation is performed at the level of the general
practice. In the experimental group (125 patients) a minimal cognitive-behavioural intervention is
provided by the GP. Information from the screening questionnaire is the starting point of treatment.
Emphasis is put on adjustment of catastrophising thoughts, re-activation, and coping with concerns
and disability. The GPs in the control group provide usual care for low back pain (125 patients).
Outcomes are assessed at 6, 12, 26, 52 and 78 weeks after inclusion. Primary outcome measures
include: functional disability; distress, depression, anxiety and somatisation; work absenteeism; pain
severity; and perceived benefit. Intermediate outcomes are: kinesiophobia; coping with pain; fear
avoidance and beliefs. Direct and indirect costs are assessed along with the clinical outcomes, and a
cost-effectiveness analysis is carried out.