Cognitive Functional Therapy Compared With Sham-treatment for Low Back Pain

Summary

Participation Requirements

Description

The aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention, comprised of photobiomodulation using a detuned device + talking about neutral topics, for pain intensity and disability at the end of the treatment and at 3-month follow-up. The secondary aims will...

The aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention, comprised of photobiomodulation using a detuned device + talking about neutral topics, for pain intensity and disability at the end of the treatment and at 3-month follow-up. The secondary aims will be to investigate the effect of CFT for pain intensity and disability at 6-month follow-up, as well as the effect of the active treatment on exercise adherence, global perceived effect of improvement, functioning and therapeutic alliance at 3- and 6-month follow-up. The study was submitted to and approved by the ethics committee for research involving human subjects of the Ribeirão Preto Medical School (Ethics Committee Board from Centro Saúde Escola Cuaibá) of the University of São Paulo (HCFMRP CAE number: 26780619.0.0000.5414). This study will be a sham-controlled randomized clinical trial (RCT). The sample will be comprised of 152 participants (both genders) with non-specific CLBP who will be referred to the physiotherapy outpatient clinic from the Centro Saúde Escola Cuiabá of Ribeirão Preto Medical School - University of São Paulo (Brazil). Patients will be informed that this study will involve a sham intervention arm (fake intervention in which an inert treatment will be provided but it still can result in positive outcomes due to its psychological effects) vs. an active treatment arm, but the nature of the sham will not be elucidated (equipment detuned). After this initial assessment, participants will be randomly assigned using block randomization by simple computerized procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes: i) CFT group or ii) Sham group. As a strategy to control for the treatment fidelity on both arms of the study, we will adopt the framework developed by the NIH Behaviour Change Consortium (BCC). To control for the "Intervention Delivery", the time of therapist-patient interaction, number of sessions and the different components of the intervention administered (e.g.: in the sham-group, the time administering the sham photobiomodulation and the time spent with neutral talking), as well as video recordings during the pilot study and along the trial will be registered. Also, regular meetings to discuss the clinical cases will be performed. Furthermore, the "Intervention receipt" will be assessed in two different manners: i) on the completion of the study, each participant will be submitted to a manipulation check and they will be asked about the group they think they were at and ii) patients in both groups will be invited to summarize at the beginning of each session how the treatment impact their lives. Despite it is a sham-controlled RCT, considering the differences in the interventions administered in both study arms, it will not be possible to blind the therapists, however, patients will be blinded to randomized interventions. The assessor and the participants will not have access to what type of treatment the participant will be given. To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.

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