Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial
Authors:
- Mariana Romano de LiraMariana Romano de Lira
- Ney Meziat-FilhoNMNey Meziat-Filho
- Gabriela Zuelli Martins SilvaGSGabriela Zuelli Martins Silva
- Julia CastroJCJulia Castro
- Jessica FernandezJFJessica Fernandez
- Rinaldo Roberto de Jesus GuirroRGRinaldo Roberto de Jesus Guirro
- Roger BergRBRoger Berg
- Thais Cristina ChavesTCThais Cristina Chaves
- 6 March 2025
- journal article
- Published by BMJ in British Journal of Sports Medicine
- Vol. 59 (13) , 912-920
Abstract
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/.Keywords
This publication has 45 references indexed in Scilit:
- Effect of Graded Sensorimotor Retraining on Pain Intensity in Patients With Chronic Low Back PainJAMA, 2022
- Assessment of blinding in randomized controlled trials of antidepressants for depressive disorders 2000–2020: A systematic review and meta-analysiseClinicalMedicine, 2022
- Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back PainJAMA Psychiatry, 2021
- Cognitive functional therapy in patients with non‐specific chronic low back pain—a randomized controlled trial 3‐year follow‐upEuropean journal of pain, 2019
- National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathyEuropean Spine Journal, 2017
- Random guess and wishful thinking are the best blinding scenariosContemporary Clinical Trials Communications, 2016
- Efficacy of classification‐based cognitive functional therapy in patients with non‐specific chronic low back pain: A randomized controlled trialEuropean journal of pain, 2012
- Outcome measures in chronic low back painEuropean Spine Journal, 2010
- Clinical Effectiveness of Individual Cognitive Behavioral Therapy for Depressed Older People in Primary CareArchives of General Psychiatry, 2009
- AN INDEX FOR ASSESSING BLINDNESS IN A MULTI-CENTRE CLINICAL TRIAL: DISULFIRAM FOR ALCOHOL CESSATION—A VA COOPERATIVE STUDYStatistics in Medicine, 1996