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

Low Back Pain, Recurrent Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04979403
• Other study ID #: 2021-2227
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2023
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Recurrent

Intervention

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.

Locations

Country	Name	City	State
Canada	Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)	Quebec City	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Laval University	Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Fonds de la Recherche en Santé du Québec, Ordre professionnel de la physiothérapie du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate of participants	The number of participants contacted divided by the number of participants recruited.	Baseline
Primary	Physiotherapists adherence to intervention	Physiotherapists will complete a list of interventions used after each interventions (8 interventions on period of 6 weeks).	Week 6
Primary	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
Primary	Specific challenges	Using semi-structured interview with the physio.	Through data collection completion, an average of 1 year
Primary	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
Primary	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	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).	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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.	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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).	Baseline, Weeks 6, 12 and 24
Secondary	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.	Baseline, Weeks 6, 12 and 24
Secondary	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.	Baseline, Week 6
Secondary	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.	Baseline, Week 6