An interventional study of Physiotherapy in Low Back Pain, Recurrent, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
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):
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.
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
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
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
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.
Recruitment rate of participants
The number of participants contacted divided by the number of participants recruited.
Time frame: Baseline
Physiotherapists adherence to intervention
Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).
Time frame: 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.
Time frame: Week 6
Specific challenges
Using semi-structured interview with the physio.
Time frame: 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.
Time frame: 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).
Time frame: Week 6
Physical functioning (ODI)
The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability).
Time frame: Baseline, Weeks 6, 12 and 24
Pain intensity (NRS)
The Numeric Rating Scale (NRS) is an 11-point scale used to score the intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline, Weeks 6, 12 and 24
Quality of life (SF-12)
The 12-Item Short Form Survey is a self-completed questionnaire counting 12 questions on eight mental and physical health domains. The score is calculated by a specific calculator that compares the score to the general population.
Time frame: Baseline, Weeks 6, 12 and 24
Fear of movement (TSK-11)
The Tampa Scale of Kinesiophobia is a self-completed questionnaire used to assess fear of movement using 11 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).
Time frame: Baseline, Weeks 6, 12 and 24
Catastrophizing thoughts (PCS)
The Pain Catastrophizing Scale (PCS) is a self-completed questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).
Time frame: Baseline, Weeks 6, 12 and 24
Self-efficacy (CPSES)
The Chronic Pain Self-Efficacy Scale (CPSES) (short form) is a self-completed questionnaire of 6 questions measuring self-efficacy on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).
Time frame: Baseline, Weeks 6, 12 and 24
Participant's expectations
Participant's expectations regarding treatment will be measured with a self-completed questionnaire of three 7-level Likert questions on pain, physical functioning and participation ranging from 0 (way better) to 6 (way worst).
Time frame: Baseline, Weeks 6, 12 and 24
Central Sensitization (CSI)
The Central Sensitization Index (CSI) is a self-completed questionnaire of 9 questions measuring central sensitization on a 5-point scale from 0 (never, low level of central sensitization) to 5 (always, high level of central sensitization).
Time frame: Baseline, Weeks 6, 12 and 24
Global rating of change (GRC)
The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change oh health status after the intervention.
Time frame: Baseline, Weeks 6, 12 and 24
Pain pressure threshold
Pain pressure thresholds will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a digital algometer before and after an exercise of wrist flexion (maintaining 25% of the maximal voluntary contraction activity during 4 minutes) to test the exercise-induced hypoalgesia paradigm.
Time frame: Baseline, Week 6
Temporal summation
Temporal summations will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a pinprick before the exercise of wrist flexion.
Time frame: Baseline, Week 6
Plan to share: Yes — Individual participant data (of all primary and secondary outcomes) will be available in a supplementary table when publishing the results of the study.
Supporting information: Study protocol
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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