Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 psychosocial subscale

• Functional limitations, scoring ≥ 15% on the Oswestry Disability Index (ODI)

Locations
Other Locations
Canada
Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
RECRUITING
Québec
Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
NOT_YET_RECRUITING
Québec
Contact Information
Primary
Hugo Massé-Alarie, PhD
hugo.masse-alarie@fmed.ulaval.ca
(418) 529 9141
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 96
Treatments
Experimental: Active rTMS + PiP
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.
Sham_comparator: Sham rTMS + 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.
Active_comparator: Usual physiotherapy
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.
Related Therapeutic Areas
Sponsors
Collaborators: Foundation for Physical Medicine and Rehabilitation, Chronic Pain Centre of Excellence for Canadian Veterans
Leads: Laval University

This content was sourced from clinicaltrials.gov