Cognitive Functional Therapy (CFT) compared with a combined Core Training Exercise and Manual Therapy in patients with non-specific chronic low back pain: a study protocol for a randomized controlled trial

Abstract

Background: Chronic non-specific low back pain (CNSLBP) is a public health issue associated with a complex interaction of biopsychosocial factors. Cognitive Functional Therapy is a multidimensional approach for CNSLBP which targets negative cognitions and maladaptive functional behaviors (via body relaxation, control and extinction of protective and safety behaviors). Since the evidence about the efficacy of CFT is still limited, it is important to perform clinical trials with the aim of comparing CFT with other interventions commonly used in clinical practice of physiotherapy. The current study will investigate the efficacy of Cognitive Functional Therapy (CFT) compared to combined Core Training exercise and manual therapy (CORE-MT) on pain and disability in patients with CNSLBP. Methods: Two-group, randomized controlled trial with blinded assessors. We will recruit 148 patients with CNSLBP in a private clinic in the city of Campinas, Brazil. The experimental group will receive five one-hour individualized sessions of CFT within a period of two months. The control group will receive five one-hour individualized sessions of CORE-MT within a period of two months. Patients will be assessed pre-intervention, post-intervention and after six and twelve months. The primary outcomes will be pain intensity and disability two months after first intervention session; secondary outcomes will be pain intensity and disability at six and twelve months, as well as global perceived effect and patient satisfaction at two, six and twelve months after the first intervention session. Non-specific predictors, moderators and mediators of outcomes will also be analyzed. Discussion: The result of a high-quality randomized controlled clinical trial involving CFT will assist physiotherapists in the clinical decision-making process. The present study will have a sample size capable of detecting relevant clinical effects of treatment with a low risk of bias. Trial registration: The protocol has been written according to the SPIRIT statement to enhance transparency of content and completeness, has been approved by the Augusto Motta University Center Ethics Committee (research protocol number 2.219.742) and the findings of the trial will be reported following the CONSORT statement and the TIDieR checklist. Trial registration number: NCT03273114