Clinical trial NCT04979403: Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
Official title: Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients With Chronic Low Back Pain With a High Level of Psychosocial Factors: a Feasibility and Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Keywords: Chronic low back pain
Psychosocial factors
Physiotherapy
Interventions
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
name: Fonds de la Recherche en Santé du Québec
name: Ordre professionnel de la physiothérapie du Québec
First posted: 2021-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Non-specific chronic low back pain (\> 3 months)
* High level of psychosocial factors (a high level using the Start Back Screening Tool, i.e., cut-off of at least 4 points (total score) and at least 4 points (sub-score with questions 5 to 9)).

Exclusion Criteria:

* Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, infection)
* Neuropathic conditions (e.g., radiculopathy).
* Currently in litigation with paying agencies

Primary outcomes:
measure: Recruitment rate of participants
timeFrame: Baseline
measure: Physiotherapists adherence to intervention
timeFrame: Week 6
measure: Risk of contamination between treatment sites
timeFrame: Week 6
measure: Specific challenges
timeFrame: Through data collection completion, an average of 1 year
measure: Retention of participants
timeFrame: Baseline, when a participant drop out
measure: Participants adherence to intervention
timeFrame: Week 6
Secondary outcomes:
measure: Physical functioning (ODI)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Pain intensity (NRS)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Quality of life (SF-12)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Fear of movement (TSK-11)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Catastrophizing thoughts (PCS)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Self-efficacy (CPSES)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Participant's expectations
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Central Sensitization (CSI)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Global rating of change (GRC)
timeFrame: Baseline, Weeks 6, 12 and 24
measure: Pain pressure threshold
timeFrame: Baseline, Week 6
measure: Temporal summation
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
state: Quebec
Study officials:
affiliation: Laval University
name: Hugo Massé-Alarie, PhD
role: PRINCIPAL_INVESTIGATOR
References: