Effectiveness of cognitive functional therapy compared to core training and manual therapy in pain and disability in patients with nonspecific chronic low back pain: a randomized controlled trial

Abstract

Introduction: Chronic nonspecific low back pain (CLBP) is a public health problem associated with a complex interaction between biopsychosocial factors. Cognitive-Functional Therapy (CFT) is a behavioral intervention aimed at multiple aspects of low back pain. This approach focuses on changing the patient's beliefs, confronting their fears, reframing pain and the mechanisms involved in this process, increasing physical and mental resistance, and improving body control. This is done through functional tasks, where the individual is trained to reduce excessive trunk muscle activity and generate pain-related behavioral changes, such as provocative postures and movements. Since the evidence on efficacy is still limited, it is important to conduct clinical trials where CFT is compared to other interventions commonly used in clinical practice. Objectives: To investigate the efficacy of CFT compared to Core Training associated with Manual Therapy (CORE-TM) in patients with CLBP. Methods: Randomized controlled clinical trial of two parallel groups with a blinded evaluator. A total of 148 patients with LCBP are being recruited from a private clinic in the city of Campinas, Brazil. Intervention I: 5 one-hour sessions with CFT for two months. Intervention II: 5 one-hour sessions of CORE-TM for two months. The data presented in this study will refer to partial analyses of the results of 90 participants and without differentiating the intervention groups, in order to maintain blind randomization until the end of the collections and avoid biases in the study. The primary outcomes are pain intensity and disability assessed two months after randomization; the secondary outcomes are pain intensity and disability at six and twelve months, as well as the perceived global effect and patient satisfaction at two, six and twelve months after randomization. Results: Partial results showed that participants showed statistically significant improvements in both primary outcomes pain (Mean Difference -1.5, 95% Confidence Interval -2.2 to -0.9) and disability (Mean Difference -8.5, 95% Confidence Interval -11.2 to -5.9) two months after randomization. The treatment effect was sustained six months and one year after the intervention in the pain outcome, and at six months in the disability outcome. Conclusion: The treatments provided improvements in pain and disability when analyzed together. A complete analysis of the results has the potential to provide relevant information for clinical practice.