Functional cognitive therapy compared with pilates for elderly patients with chronic low back pain: a randomized controlled telerrehabilitation trial

Abstract

Introduction: Chronic low back pain (CLBP) is a public health problem. Strong evidence suggests that CLBP is the result of an interaction between biopsychosocial factors, however, most treatments are still based on the biomedical model. Cognitive Functional Therapy (CFT) is an intervention that addresses potentially modifiable multidimensional aspects of pain. Four clinical trials showed that CFT is more effective in reducing disability than other interventions, however, without including elderly participants in the samples. The Covid-19 pandemic enabled the popularization of telerehabilitation, but there are still no clinical trials testing the
effectiveness of CFT via telecare compared to other interventions commonly used in physiotherapists' clinical practice. Objective: To investigate the effectiveness of CFT compared with Pilates in the disability of elderly patients with chronic low back pain.
Methods: Randomized controlled clinical trial with parallel group allocation. 200 participants aged 65 and over with low back pain for more than 3 months will participate in the study. Recruitment will take place through advertising on the internet. Experimental group: two individual sessions and four to eight CFT sessions. Control group: six to 10 Pilates sessions. The primary clinical outcome will be disability due to low back pain (Quebec Low Back Pain Questionnaire) assessed 12, 24 and 48 weeks after the start of treatment. The primary economic outcome will be Quality-adjusted life years (QALYs) assessed at 48 weeks after the start of treatment. There will be an intention-to-treat analysis using linear mixed models to compare mean differences in low back pain disability between the intervention arms. Analyzes will be performed using RStudio and a statistical significance level of 5%. Discussion: To our knowledge, this is will be the first RCT investigating the effectiveness of CFT via tele rehabilitation for older adults with nonspecific low back pain. As evidence of CFT effectiveness in the context of tele rehabilitation for older adults is still limited, this study will help physiotherapists in clinical decision-making.