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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.

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