Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?

NCT ID: NCT04979403

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-10-30

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.

Conditions

Low Back Pain, Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care in physiotherapy

The usual care group will receive interventions recommended by clinical guidelines: education on the nature of LBP, advice to stay active and to continue usual activities, specific exercise programs combined with orthopedic manual therapy.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

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.

Psychologically-informed physiotherapy intervention

The psychologically-informed physiotherapy group will receive the control intervention enhanced with specific interventions targeting psychosocial factors (e.g., positive reinforcement, mindfulness-based stress reduction, diaphragmatic breathing, graded exposure). Most of these techniques are efficient to mitigate the impact of psychological factors such as anxiety and fear of movement. To standardize the psychologically-informed physiotherapy approach, physiotherapists will receive a two-day training course by a physiotherapist expert with this approach in chronic pain conditions (Alain Gaumond).

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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.

Interventions

Physiotherapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale

OTHER

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Ordre professionnel de la physiothérapie du Québec

UNKNOWN

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Hugo Massé-Alarie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hugo Massé-Alarie, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

2021-2227

Identifier Type: -

Identifier Source: org_study_id