Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.
Adults between 18 and 65 years old
Military Veterans with non-specific chronic low back pain (> 3 months, > 50% of the days in the last 6 months)
High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool
Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)
Non-musculoskeletal conditions causing low back pain (e.g., neoplasia, fracture)
Diagnosis of drug or alcohol abuse
Change of drug dosage in the last month for the treatment of pain or mental health
Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy
Parallel
Active rTMS
DeviceA figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5 s at 10 Hz with 15 s intertrain intervals, for a total of 3000 pulses per session, will be used. The coil will be positioned over the left dorsolateral PFC using the BeamF3 methods.
Sham rTMS
DeviceA sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex).
Psychologically-informed physiotherapy (PiP)
Other interventionParticipants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and stress management strategies (e.g. breathing techniques). Participants allocated to PiP groups will have access to a website offering support information related to understanding their pain (e.g. pain neuroscience education), myths and false beliefs related to back pain, understanding the impact of psychological factors on their pain, self-management strategies, and healthy lifestyle habits. This site will be freely available to participants during the course of the study.
Usual physiotherapy
Other interventionParticipants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy.
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). The total score ranges from 0 (no disability) to 100% (maximal disability).
Pain intensity (NPRS)
The Numerical Pain Rating Scale (NPRS) is an 11-point scale used to measure the mean intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).
Quality of life (EQ-5D-5L)
The EQ-5D-5L is a self-administrated questionnaire that contains 5 questions, each rated on a 5-point scale and mesuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions define 5\^5 = 3125 possible health states, which can be converted into a Canadian weighted index score. This index score ranges from -0.148 (lowest value assigned to a health state) to 0.949 (highest value assigned to a health state).
Depression symptoms (PHQ)
The Patient Health Questionnaire is a self-administrated questionnaire of 9 questions used to diagnose depression and grade severity of symptoms. The scale ranges from 0 to 27; a higher score means more depressive symptoms.
Pain catastrophizing (PCS)
The Pain Catastrophizing Scale (PCS) is a self-administrated 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).
Adverse events
All adverse events and reasons for drop-out will be recorded and reported.
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Laval University
Lead sponsor
Chronic Pain Centre of Excellence for Canadian Veterans
Collaborator
Foundation for Physical Medicine and Rehabilitation
Collaborator
