Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial

• DOI: 10.1016/j.jphys.2018.02.018
• Publication Date: 2018-06-11T15:49:43Z
• Authors: Fabiana Terra Cun...; Cíntia Pereira de...; Jessica Fernandez; Julia Castro; Paula dos Santos ...; Elizana Rodrigues...; Nathalia Cristina...; Felipe José Jandr...; Renato Santos de ...; Leandro Alberto C...; Luís Cláudio Lemo...; Ney Meziat-Filho
• Keywords: Biopsychosocial model; Manual therapy

Chronic low back pain is a public health problem, and there strong evidence that it associated with complex interaction of biopsychosocial factors. Cognitive functional therapy an intervention deals potentially modifiable multidimensional aspects (eg, provocative cognitive, movement lifestyle behaviours). There (from single randomised, controlled trial) cognitive better than combined manual motor control exercise. However, this study had significant methodological shortcomings including the failure to carry out intention-to-treat analysis considerable loss follow-up participants. It important replicate in another domain through randomised clinical trial similar objectives but correcting these shortcomings. To investigate efficacy compared exercise on disability at 3 months patients chronic non-specific pain. Two-group, multicentre blinded assessors. One hundred forty-eight participants has persisted for > no specific spinal pathology will be recruited from school clinic Centro Universitário Augusto Motta private city Rio de Janeiro, Brazil. Four 10 sessions therapy. The physiotherapists who treat group have previously attended 2 workshops two different tutors method. Such completed 106 hours training, patient examinations, as well conducting pilot under supervision physiotherapist years experience exercises. Participants treated by average exercises, isolated contractions deep abdominal muscles. primary outcome measures intensity after randomisation. Secondary outcomes assessed 6 12 randomisation, both global perceived effect satisfaction 3, potential mediators brief screening questions anxiety, social isolation, catastrophisation, depression, fear movement, stress sleep. Non-specific predictors moderators include age, gender, duration pain, chronicity risk (Örebro Start Back score), number areas, stressful life event, MRI scan imaging, family history. Intention-to-treat performed. Linear mixed models used compare mean differences intensity, between arms. treatment performed using causal mediation methods described Imai colleagues. baseline variables evaluated treatment, terms models. A level statistical significance 5% analysis. All analyses RStudio. This whether results first are reproducible. present sample size capable detecting clinically relevant effects bias. In pragmatic terms, designed reproduce would practice trained works therapy, which increases relevance study. comprises strategy widely As still limited, high quality help decision-making.