Oral Presentation 51st International Society for the Study of the Lumbar Spine Annual Meeting 2025

Efficacy of cognitive functional therapy for pain intensity and disability in patients with chronic non-specific chronic low back pain: a randomized sham-controlled trial (113743)

Mariana MRL Romano de Lira 1 , Ney Armando NM de Mello Meziat Filho 2 3 , Gabriela GZMS Zueli Martins Silva 1 , Julia JC Castro 2 , Jessica JF Fernandez 2 , Rinaldo Roberto RRJG de Jesus Guirro 1 , Roger RBRP Berg Rodrigues Pereira 4 , Thais Cristina TCC Chaves 1 4
  1. Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo - USP, Ribeirão Preto, São Paulo, Brazil
  2. Postgraduate Program in Rehabilitation Sciences , Augusto Motta University Center , Rio de Janeiro , RJ, Brazil
  3. School of Rehabilitation Science, Faculty of Health Sciences, Institute of Applied Health Sciences, McMaster University , Hamilton , Ontario , Canada
  4. Postgraduate Program in Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil

INTRODUCTION

Chronic low back pain (CLBP) is the leading disability-related health condition worldwide. The biopsychosocial model posits that low back pain results from a dynamic interaction between social, psychological, and biological factors, and this perspective is recommended for managing CLBP. Cognitive Functional Therapy (CFT) is a promising multidimensional, biopsychosocial approach to treating CLBP. However, no study has yet examined the efficacy of CFT compared to a placebo. The aim of this study was to investigate the efficacy of CFT versus a sham procedure for reducing disability and pain intensity in patients with non-specific CLBP.

METHODS

This study was conducted in a primary care public health service in Brazil. A total of 152 adults with CLBP were randomly assigned to receive six one-hour individualized sessions of either Cognitive Functional Therapy (CFT) (n=76) or a sham procedure (neutral talk + detuned photobiomodulation equipment) (n=76). The primary outcomes were pain intensity (measured by the numeric pain rating scale, 0-10) and disability (measured by the Oswestry Disability Index, 0-100) at six weeks. Patients were assessed pre-intervention, post-intervention (at six weeks), and at three and six months after randomization.

RESULTS

We obtained primary outcome data from 74 participants in each group (97.36%). Participants in the CFT group attended an average of 4.78 treatment sessions (SD = 1.76), while the sham group received an average of 5.44 sessions (SD = 1.07). The mean session duration was 35 minutes (SD = 8.43) for the CFT group and 33 minutes (SD = 3.16) for the sham group. The majority of participants (over 60%) in both groups believed they received the active treatment. Only one participant in the CFT group and six participants in the sham group correctly identified that they received the sham intervention. The CFT group showed large effect sizes in pain intensity (mean difference [MD] = -1.72; 95% CI = -2.38 to -1.07; effect size = 0.80) and disability (MD = -9.88; 95% CI = -13.08 to -6.68; effect size = 0.95) post-intervention (primary outcome) (Fig 1a and 1b). The same positive results were found for the secondary outcomes of function and pain self-efficacy (Fig 2a and 2b). These effects were maintained at the 3-month and 6-month follow-ups. 

DISCUSSION

Our findings showed that CFT demonstrated efficacy with large and clinically meaningful effect sizes for both pain intensity and disability outcomes. The secondary outcomes at all follow-ups supported the primary findings and confirmed the superiority of CFT over the sham intervention for patients with chronic low back pain (CLBP).

 

 

 

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  1. [1] Thiveos L, Kent P, Pocovi NC, O'Sullivan P, Hancock MJ, (2024), Cognitive Functional Therapy for Chronic Low Back Pain: A Systematic Review and Meta-Analysis. , Physical Therapy