Brain stimulation plus psychologically informed physiotherapy for chronic low back pain in Veterans
Official title: Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
Run by Laval University · NCT06999772 · Data updated 2026-11-12
This study will test whether adding non-invasive brain stimulation to psychologically informed physiotherapy helps Veterans with chronic low back pain and high psychological risk factors reduce pain and improve physical function.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Laval University Academic / other |
| Locations | 2 sites (Québec, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06999772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are Veterans aged 18–65 with non-specific chronic low back pain (>3 months, present >50% of days in the past 6 months), high psychosocial risk (Start Back score ≥4), and functional limitation (ODI ≥15%).
✕Probably not a fit
Patients with specific non-musculoskeletal causes of back pain, active drug or alcohol abuse, recent changes in pain or mental health medications, or standard rTMS exclusions (for example, prior seizure, cochlear implant, or pregnancy) are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial will assign Veterans with chronic low back pain and elevated psychosocial risk to one of three arms: rTMS plus psychologically informed physiotherapy (PiP), PiP with sham rTMS, or usual physiotherapy. The active intervention combines repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, with PiP that integrates cognitive and emotional strategies into standard physiotherapy. Treatments are delivered over an 8-week program, and outcomes are measured with validated questionnaires at baseline, 2, 8, and 26 weeks. The primary outcome is physical functioning, with secondary outcomes including pain intensity, quality of life, fear of movement, catastrophizing, self-efficacy, depression, medication use, and PTSD symptoms.
Why it matters
Potential benefit: If successful, the combination could produce greater improvements in physical function, reduce pain, and lower psychological barriers to recovery compared with physiotherapy alone.
How similar studies have gone: Psychologically informed physiotherapy has shown benefit in randomized trials and rTMS has demonstrated effects on pain and mood in other chronic pain populations, but combining rTMS with PiP is a relatively novel approach with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
-
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
Québec, Quebec, Canada Recruiting -
Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, Canada Not yet recruiting
Study contacts
- Principal investigator: Hugo Massé-Alarie, PhD — Laval University
- Study coordinator: Hugo Massé-Alarie, PhD
- Email: hugo.masse-alarie@fmed.ulaval.ca
- Phone: (418) 529 9141
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.