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

NCT04979403 | Completed

• 1 other identifier: 2021-2227
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Recurrent

Keywords

Chronic low back pain; Psychosocial factors; Physiotherapy; Interventions

Outcome Measures

Primary Outcomes (6)

• Recruitment rate of participants

  The number of participants contacted divided by the number of participants recruited.

  Baseline

• Physiotherapists adherence to intervention

  Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).

  Week 6

• Risk of contamination between treatment sites

  The list of interventions used by physiotherapists at each site will be compared to evaluate the risk of contamination between treatment sites.

  Week 6

• Specific challenges

  Using semi-structured interview with the physio.

  Through data collection completion, an average of 1 year

• Retention of participants

  The number of participants who completed the study divided by the number of participants that were recruited.

  Baseline, when a participant drop out

• Participants adherence to intervention

  Participants will measure their adherence to intervention on a Numeric Rating Scale from 0 (not adherent at all) to 10 (completely adherent).

  Week 6

Secondary Outcomes (11)

• Physical functioning (ODI)

  Baseline, Weeks 6, 12 and 24

• Pain intensity (NRS)

  Baseline, Weeks 6, 12 and 24

• Quality of life (SF-12)

  Baseline, Weeks 6, 12 and 24

• Fear of movement (TSK-11)

  Baseline, Weeks 6, 12 and 24

• Catastrophizing thoughts (PCS)

  Baseline, Weeks 6, 12 and 24

Study Arms (2)

Usual care in physiotherapy

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Psychologically-informed physiotherapy intervention

EXPERIMENTAL

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).

Other: Physiotherapy

Interventions

Physiotherapy 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; Usual care in physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Laval University: lead
• Ordre professionnel de la physiothérapie du Québec: collaborator

Study Sites (1)

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

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (2)

• Masse-Alarie H, Desgagnes A, Cote-Picard C, Liberty O, Langevin P, Piche M, Tousignant-Laflamme Y. Comparisons of the effects of psychologically-informed and usual physiotherapy on pain sensitivity in chronic low back pain: an exploratory randomized controlled trial. Arch Physiother. 2025 Feb 17;15:32-41. doi: 10.33393/aop.2025.3323. eCollection 2025 Jan-Dec.

  PMID: 39974748 RESULT

• Desgagnes A, Cote-Picard C, Gaumond A, Langevin P, Piche M, Page G, Pinard AM, Tousignant-Laflamme Y, Masse-Alarie H. Efficacy of a Psychologically-Informed Physiotherapy Intervention in Patients with Chronic Low Back Pain at High Risk of Poor Prognosis: A Pilot and Feasibility Randomized Controlled Trial. Physiother Can. 2024 May 8;76(2):163-174. doi: 10.3138/ptc-2023-0038. eCollection 2024 May.

  PMID: 38725600 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Hugo Massé-Alarie, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 28, 2021
• Study Start: September 15, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available when the results of the study will be published (around winter 2023) for an unlimited period.
• Access Criteria: The data will become available when the results of the study will be published (around winter 2023) for an unlimited period.

Locations

CA (1)