Brief intervention, physical exercise and cognitive behavioural group therapy for patients with chronic low back pain (The CINS trial)

Abstract Background and Objective Cognitive‐behavioural treatments (CBT) and physical group exercise (PE) have both shown promising effects in reducing disability and increasing work participation among chronic low back pain (CLBP) patients. A brief cognitive intervention (BI) has previously been demonstrated to reduce work disability in CLBP. The aim of this study was to test if the effect of BI could be further increased by adding either group CBT or group PE. Methods A total of 214 patients, all sick listed 2–10 months due to CLBP, were randomized to BI ( n = 99), BI + group CBT ( n = 55) or BI + group PE ( n = 60). Primary outcome was increased work participation at 12 months, whereas secondary outcomes included pain‐related disability, subjective health complaints, anxiety, depression, coping and fear avoidance. Results There were no significant differences between the groups in work participation at 12 months follow‐up (χ 2 = 1.15, p = 0.56). No significant differences were found on the secondary outcomes either, except for a statistically significant reduction (time by group) in pseudoneurology one domain of subjective health complaints (sleep problems, tiredness, dizziness, anxiety, depression, palpitation, heat flushes) ( F 2,136 = 3.109, p = 0.048) and anxiety ( F 2,143 = 4.899, p = 0.009) for the groups BI + group CBT and BI + group PE, compared to BI alone. However, these differences were not significant in post hoc analyses (Scheffé adjusted). Conclusion There was no support for an effect of the added group CBT or group PE treatments to a brief cognitive intervention in this study of patients on sick leave due to low back pain. Significance Our study demonstrates that treatments that previously were found to be effective and are included in most treatment guidelines, such as group cognitive‐behavior therapy and exercise, were not effective in this given context compared to a brief, cognitive intervention. This implies that an optimized brief intervention is difficult to outperform in patients on sick leave due to low back pain.