Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial

OBJECTIVE: This study investigated the efficacy of cognitive functional therapy (CFT) versus a sham procedure for pain intensity and disability for patients with non-specific chronic low back pain (CLBP). METHODS: This is a randomised sham-controlled trial conducted in a primary care public health service. A total of 152 participants were randomly assigned to the CFT group (n=76) and the sham group (n=76). The CFT group received six 1 hour individualised sessions; the sham procedure group received six individual sessions of neutral talking+detuned photobiomodulation (low-level laser therapy) equipment. Both groups received an education booklet with information on strategies for CLBP self-management. Primary outcomes were pain intensity and disability at 6 weeks. Participants were assessed preintervention, postintervention (at 6 weeks), and 3 and 6 months after randomisation. RESULTS: We obtained primary outcome data from 97.4% (n=74) of participants in the CFT group and 98.7% (n=75) from the sham group. The CFT group showed greater effects in pain intensity (mean difference (MD)=-1.8; 95% CI -2.5 to -1.1) and disability (MD=-9.9; 95% CI -13.2 to -6.5) postintervention compared with the sham group. The effect remained at the 3-month and 6-month follow-ups. CONCLUSIONS: CFT showed sustained clinical efficacy compared with a sham procedure for treating pain intensity and disability in patients with CLBP. TRIAL REGISTRATION NUMBER: This trial was registered in ClinicalTrials.gov, NCT04518891 and was previously published https://pubmed.ncbi.nlm.nih.gov/35788240/.