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

Summary

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 (eg, provocative cognitive, movement and lifestyle behaviors). In order to better understand the contextual effects, the aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP).

This study is a randomized clinical trial (RCT) 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 participants. The sham group will attend six sessions: consisted of 30 minutes of photobiomodulation using a detuned device and more 15 minutes of talking about neutral topics. Participants will be assessed pre and post-intervention, three months and six months after randomization. Patients from both groups also will receive an educational booklet. 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 treatment administered (active vs. sham).

The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Treatment effect for the primary and secondary outcomes will be estimated using mixed linear models.

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.

Conditions

• Chronic Low-back Pain

Interventions

BEHAVIORAL

Cognitive Functional Therapy (CFT)

Cognitive functional therapy (CFT) is an intervention that deals with potentially modifiable multidimensional aspects of pain (e.g. provocative cognitive, movement and lifestyle behaviours). Treatment with CFT will be individualised, the physiotherapist will listen to the complete patient pain history and the intervention will be focused on individual needs. A detailed examination will be crucial in identifying the modifiable multidimensional mediators of pain and disability (provocative cognitive, pain, movement and lifestyle behaviors) of each participant.

DEVICE

Sham intervention

Due to the impossibility of applying placebo exercise, the control intervention in this study will be based on successful reports of placebo intervention in patients with chronic low back pain in the literature (Placebo photobiomodulation + neutral talking control)

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Mariana R Lira, Master

• Ney A Meziat, PhD · Augusto Motta University Center (UNISUAM)

• Thais C Chaves, PhD · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-17

Primary Completion

2023-06-30

Completion

2023-12-31

Countries

• Brazil

Study Locations