Testing Combined Brain Stimulation and Psychologically Informed Physiotherapy to Improve Chronic Low Back Pain in Veterans
Led by Laval University · Updated on 2026-01-20
96
Participants Needed
2
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain
Research Team
H
Hugo Massé-Alarie, PhD
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Chronic Pain Centre of Excellence for Canadian Veterans
Collaborating Sponsor
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
Adults between 18 and 65 years old
Military Veterans with non-specific chronic low back pain lasting more than 3 months and present more than 50% of the days in the last 6 months
High level of psychosocial factors, scoring 4 or higher on the Start Back Screening Tool
Functional limitations, scoring 15% or higher on the Oswestry Disability Index
You will not qualify if you...
Non-musculoskeletal causes of low back pain such as cancer or fracture
Diagnosis of drug or alcohol abuse
Change in pain or mental health medication dosage in the last month
Any specific exclusion criteria for rTMS including history of seizures, cochlear implant, or pregnancy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
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)
Treatment
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
Follow-up
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)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial.