- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04979403
Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
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 Overview
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):
- 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;
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amélie Desgagnés, MSc cand, PT
- Phone Number: 581-982-7924
- Email: amdes75@ulaval.ca
Study Contact Backup
- Name: Claudia Côté-Picard, PhD cand, PT
- Email: claudia.cote-picard.2@ulaval.ca
Study Locations
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Quebec
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Quebec City, Quebec, Canada, G1M 2S8
- CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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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.
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Experimental: 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate of participants
Time Frame: Baseline
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The number of participants contacted divided by the number of participants recruited.
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Baseline
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Physiotherapists adherence to intervention
Time Frame: Week 6
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Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).
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Week 6
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Risk of contamination between treatment sites
Time Frame: Week 6
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The list of interventions used by physiotherapists at each site will be compared to evaluate the risk of contamination between treatment sites.
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Week 6
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Specific challenges
Time Frame: Through data collection completion, an average of 1 year
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Using semi-structured interview with the physio.
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Through data collection completion, an average of 1 year
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Retention of participants
Time Frame: Baseline, when a participant drop out
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The number of participants who completed the study divided by the number of participants that were recruited.
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Baseline, when a participant drop out
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Participants adherence to intervention
Time Frame: Week 6
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Participants will measure their adherence to intervention on a Numeric Rating Scale from 0 (not adherent at all) to 10 (completely adherent).
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical functioning (ODI)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Pain intensity (NRS)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Quality of life (SF-12)
Time Frame: Baseline, Weeks 6, 12 and 24
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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.
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Baseline, Weeks 6, 12 and 24
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Fear of movement (TSK-11)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Catastrophizing thoughts (PCS)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Self-efficacy (CPSES)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Participant's expectations
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Central Sensitization (CSI)
Time Frame: Baseline, Weeks 6, 12 and 24
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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).
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Baseline, Weeks 6, 12 and 24
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Global rating of change (GRC)
Time Frame: Baseline, Weeks 6, 12 and 24
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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.
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Baseline, Weeks 6, 12 and 24
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Pain pressure threshold
Time Frame: Baseline, Week 6
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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.
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Baseline, Week 6
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Temporal summation
Time Frame: Baseline, Week 6
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Temporal summations will be measured at 3 sites (L4-L5 paravertebral, upper and lower legs) using a pinprick before the exercise of wrist flexion.
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Baseline, Week 6
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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