Brain stimulation plus psychologically informed physiotherapy for chronic low back pain in Veterans
Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 2 sites (Québec, Quebec and 1 other locations) |
| Trial ID | NCT06999772 on ClinicalTrials.gov |
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.
Who should consider this trial
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%).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Québec, Quebec and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.