Actively Recruiting
Led by Laval University · Updated on 2026-01-20
96
Participants Needed
2
Research Sites
30 weeks
Total Duration
L
Laval University
Lead Sponsor
C
Chronic Pain Centre of Excellence for Canadian Veterans
Collaborating Sponsor
Chronic low back pain (CLBP) is a significant health issue among military Veterans in Canada, often causing disability and economic challenges. Current treatments have limited success, especially as they may miss important emotional and cognitive factors influencing pain. This trial investigates whether adding non-invasive brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to psychologically informed physiotherapy (PiP) can better improve physical function in Veterans with CLBP and related psychological challenges. Participants will be randomly assigned to one of three groups: active rTMS combined with PiP, sham (placebo) rTMS combined with PiP, or usual physiotherapy (UP). The study involves an 8-week intervention period. In the first two weeks, brain stimulation sessions occur daily, then from weeks 3 to 8, brain stimulation and physiotherapy are given separately twice a week. Usual physiotherapy participants receive six sessions spread over eight weeks. PiP includes strategies addressing psychological and behavioral aspects alongside physical therapy, supported by an educational website. Throughout the study, participants complete validated questionnaires measuring physical function, pain intensity, quality of life, fear of movement, depression, self-efficacy, post-traumatic stress symptoms, medication use, and overall change. These assessments occur at baseline, 2, 8, and 26 weeks after starting treatment. The study aims to determine if combining rTMS with PiP improves outcomes more than either treatment alone, with follow-up extending to six months to monitor lasting effects and safety.
CONDITIONS
Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive 5 sessions of brain stimulation (active or sham) over 2 weeks. Each session lasts 30-40 minutes including setup and stimulation.
5 visits per week (in-person)
Duration - 6 weeks
Over 6 weeks, participants attend 11 brain stimulation sessions (active or sham) and 6 psychologically-informed physiotherapy (PiP) sessions, or 6 usual physiotherapy sessions depending on group assignment. Brain stimulation sessions last 30-40 minutes; physiotherapy sessions last 30-45 minutes. Brain stimulation and physiotherapy sessions are held separately in the same week for PiP groups.
Weekly visits for brain stimulation and physiotherapy sessions (2 visits per week) for PiP groups; or 6 physiotherapy sessions over 8 weeks for usual physiotherapy group
Duration - 18 weeks
Participants complete outcome assessments using questionnaires to measure physical functioning, pain intensity, quality of life, psychological factors, medication use, and overall symptom change.
3 follow-up visits at weeks 2, 8, and 26 (in-person or remote)
Total: 2 locations
1
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
Québec, Quebec, Canada, G1M 2S8
Actively Recruiting
2
Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, Canada, G1M 2S8
Not Yet Recruiting
H
Hugo Massé-Alarie, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Frederique Dupuis, Yannick Tousignant-Laflamme, Pascale Marier Deschênes...
https://pubmed.ncbi.nlm.nih.gov/41587077