Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial

Mariana Romano de Lira, Ney Armando de Mello Meziat-Filho, Gabriela Zuelli Martins Silva, Thaís Cristina Chaves, Mariana Romano de Lira, Ney Armando de Mello Meziat-Filho, Gabriela Zuelli Martins Silva, Thaís Cristina Chaves

Abstract

Background: Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (e.g., provocative cognitive, movement, and lifestyle behaviors).

Methods: To investigate the efficacy of CFT compared with a sham intervention for pain intensity and disability post-intervention (immediately after the last session) in patients with non-specific chronic low back pain (CLBP). This study is a randomized controlled trial in which 152 (18-60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive (1) CFT intervention or (2) sham intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of the participants. The sham group will attend six sessions: consisting of 30 min of photobiomodulation using a detuned device and more than 15 min of talking about neutral topics. Patients from both groups also will receive an educational booklet (for ethical reasons). Participants will be assessed pre and post-intervention, 3 months, and 6 months after randomization. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement, and functioning post-intervention, 3-, and 6-month follow-up. The patients and the assessor will be blinded to the treatment administered (active vs. sham).

Statistical analysis: The between-group differences (effects of treatment), as well as the treatment effect for the primary and secondary outcomes, and their respective 95% confidence intervals will be calculated by constructing linear mixed models.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT04518891 . First Posted: August 19, 2020.

Keywords: Cognitive functional therapy; Low back pain; Pain management; Placebo effect and protocols.

Conflict of interest statement

Not applicable. Prof Ney Meziat runs private workshops on CFT for chronic back pain. The other authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart according to Consolidated Standards of Reporting Trials (CONSORT) statement
Fig. 2
Fig. 2
Sham photobiomodulation application sites: nine sites will be applicated on the patient’s lumbar region: three central sites on top of the spinous processes (between T11 and T12, L2 and L3, L5 and S1); in the same direction, but laterally, three sites on the left and three on the right (on the paravertebral muscles), without any emission of therapeutic dose

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