Biopsychosocial primary care versus physiotherapy as usual in chronic low back pain: results of a pilot-randomised controlled trial

Aim: To compare the effectiveness of a biopsychosocial primary care intervention (Back on Track) with primary care physiotherapy as usual in patients with chronic low back pain (CLBP) experiencing low complex psychosocial complaints.Method: A double-blind multicentre pilot-randomised controlled trial. Twenty-five patients (>= 18 years) with non-specific CLBP (>= 12 weeks) experience low psychosocial complaints and a low to moderate level of disability. The Back on Track intervention (four individual and eight group sessions) versus physiotherapy as usual (maximally 12 individual sessions). Primary outcome: functional disability (Quebec Back Pain Disability Score) at post-treatment and 3 months follow-up.Secondary measures: Anxiety, depression, catastrophizing, pain intensity, kinesiophobia, self-efficacy, global perceived effect. Effects were analysed using linear mixed model analysis.Results: No significant differences in functional disability were found between interventions at post-treatment (mean difference 0.10, 95% CI: -12.9 to 13.1) and 3 months follow-up (mean difference -5.4, 95% CI -19.1 to 8.3). Secondary outcomes also showed no significant differences.Conclusions: No differences in effects were found between patients with CLBP experiencing low complex psychosocial complaints who receive the Back on Track intervention compared to patients receiving primary care physiotherapy as usual. Well-powered studies of sufficient methodological quality are needed to detect differences in effects.