An interventional study of Active rTMS and Sham rTMS in Chronic Low-back Pain (cLBP), sponsored by Laval University. Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.
The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 96 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
For weeks 1 and 2, participants will attend 5 brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy will be delivered in 2 separate sessions during the same week for 6 weeks. Each brain stimulation session will last 30-40 min and each physiotherapy session will last 30-45 min. Overall, participants will receive 11 sessions of rTMS only and 6 PiP sessions.
Device: Active rTMS · Other: Psychologically-informed physiotherapy (PiP)
For weeks 1 and 2, participants will attend 5 sham brain stimulation sessions. During the first phase, the session will last 30-40 min (10-20 min of installation + 20 minutes of stimulation). In the second phase (weeks 3-8), brain stimulation and physiotherapy session will be delivered in 2 separate sessions during the same week for 6 weeks. Each sham brain stimulation session will last 30-40 min and each physiotherapy will last 30-45 min. Overall, participants will receive 11 sessions of sham rTMS only and 6 PiP sessions.
Device: Sham rTMS · Other: Psychologically-informed physiotherapy (PiP)
Participants will attend 6 sessions within 8 weeks (1session /week for 4 weeks, 1 session every 2 weeks between weeks 5-8). Each physiotherapy will last 30-45 min.
Other: Usual physiotherapy
A 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.
Also known as: Repetitive Transcranial Magnetic Stimulation
A 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).
Also known as: Sham Repetitive Transcranial Magnetic Stimulation
Participants 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.
Participants 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).
Time frame: Baseline, weeks 2, 8 and 26.
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).
Time frame: Baseline, weeks 2, 8 and 26.
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).
Time frame: Baseline, weeks 2, 8 and 26.
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.
Time frame: Baseline, weeks 2, 8 and 26.
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).
Time frame: Baseline, weeks 2, 8 and 26.
Fear of movement (TSK-13)
The Tampa Scale of Kinesiophobia is a self-administrated questionnaire used to assess fear of movement using 13 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 2, 8 and 26
Self-efficacy (PSEQ-10)
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire mesuring the confidence people with ongoing pain have in performing activities while in pain, 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 2, 8 and 26.
Post-traumatic stress disorder (PCL-5)
The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item self-completed questionnaire that assesses the 20 DSM-5 symptoms of post-traumatic stress disorder on a 5-point scale ranging from 0 (not a all, no symptoms of PTSD) to 4 (extremely, severe symptoms of PTSD).
Time frame: Baseline, weeks 2, 8 and 26.
Medication use
The Medication Quantification Scale Version 4 quantifies the risk weights of the use of 36 drug sub-classes used in pain management. Each drug sub-class has a detriment weight from 0 (low risk weight) to 10(high risk weight). The total score represents the summation of each drug class used by the participant.
Time frame: Baseline, weeks 2, 8 and 26.
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 of health status after the intervention.
Time frame: Weeks 2, 8 and 26
Patient Acceptable Symptom State (PASS)
The Patient Acceptable Symptom State (PASS) measures if the participants consider their current functional and symptoms states as satisfactory or not. A visual analogue scale ranging from 0 (completely dissatisfied) to 100 (completely satsified) is used.
Time frame: Baseline, weeks 2, 8 and 26.
Adverse events
All adverse events and reasons for drop-out will be recorded and reported.
Time frame: Weeks 2, and 8
Plan to share: Yes — Deidentified individual participant data (IPD) that underlie the results reported in the published article will be made available. The study protocol will also be published.
Supporting information: Study protocol
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