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/ .