Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
Condition: Low Back Pain, Recurrent
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is presently the first cause of disability worldwide. The most recommended
      interventions by clinical guidelines are exercises and cognitive behavioral therapy although
      the effect is modest. However, no approach is superior when given to a heterogeneous group of
      subjects with chronic low back pain (CLBP). This is probably due to the multiple factors
      associated with CLBP which are biophysical, psychological and social. Thus, each patient
      presents with a unique profile of factors contributing to their pain and could benefit from
      an approach tailored to their profile. In other words, it is crucial to identify the right
      treatment, for the right person, at the right moment. For example, the presence of important
      psychological factors such as anxiety and depression are risk factors for low back pain to
      develop and persist over time. The main aim of this project is to determine the feasibility
      to perform a large clinical trial comparing the efficacy of a two physiotherapy's approaches
      to treat CLBP (i.e., a psychologically-informed physiotherapy intervention compared to usual
      physiotherapy) in patients with CLBP presenting a high level of psychological factors.
    

Detailed description: 
      Low back pain is presently the first cause of disability worldwide. The most recommended
      interventions by clinical guidelines are exercises and cognitive behavioral therapy although
      the effect is modest. However, no approach is superior when given to a heterogeneous group of
      subjects with chronic low back pain (CLBP). This is probably due to the multiple factors
      associated with CLBP which are biophysical, psychological and social. Thus, each patient
      presents with a unique profile of factors contributing to their pain and could benefit from
      an approach tailored to their profile. In other words, it is crucial to identify the right
      treatment, for the right person, at the right moment. For example, the presence of important
      psychological factors such as anxiety and depression are risk factors for low back pain to
      develop and persist over time. Empowerment of physiotherapists and patients on the optimal
      management of psychosocial factors, in addition of the usual care delivered in physiotherapy,
      may be a potent strategy to improve the treatment effect especially with patients presenting
      a complex clinical profile. This empowerment may be done through psychologically-informed
      physiotherapy, an approach incorporating strategies from cognitive behavioral therapy into
      the physiotherapy usual practice. However, the feasibility to perform a clinical trial
      including psychologically-informed physiotherapy in the context of the Quebec's healthcare
      system remains to be verified.

      The main aim of this project is to determine the feasibility to perform a pilot randomised
      controlled trial testing the efficacy of a psychologically-informed physiotherapy
      intervention in CLBP patients with a high level of psychosocial factors compared to usual
      physiotherapy. Specific aims are related to feasibility (1) and sample size estimation (2):

        1. To test (a) strategies to recruit participants with high level of psychosocial factors
           and physiotherapists (PT) (recruitment rate and retention), (b) the physiotherapists and
           participants adherence to intervention, (c) the risk of contamination between treatment
           sites and (d) specific challenges;

        2. To gather data to estimate the required sample size for a future full-scale randomized
           clinical trial using physical functioning as main outcome, and pain intensity, quality
           of life, fear of movement, catastrophizing, self-efficacy, pain pressure threshold,
           exercise-induced hypoalgesia and temporal summation as additional outcomes.

      The hypothesis is that this project will be feasible in terms of recruitment for both
      patients (~30) and PT (6-8), will show good patients and physiotherapists' adherence to
      intervention and low contamination between treatment sites. An improvement for all
      pain-related outcomes in both groups, but more in the psychologically-informed physiotherapy
      group, is also expected.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Participants from each group will receive 8 intervention sessions (45 min) over 11 weeks by a physiotherapist. For both groups, each intervention will be tailored to the patient's profile and the choice of interventions and parameters will be at the judgment of the physiotherapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a feasibility and pilot randomized clinical trial. Participants will be assigned to either the psychologically-informed physiotherapy intervention or to the usual care in physiotherapy.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic low back pain; Psychosocial factors; Physiotherapy; Interventions