Brain Stimulation + Physiotherapy for Low Back Pain

Overseen By Hugo Massé-Alarie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Non-musculoskeletal conditions, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

96 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Hugo Massé-Alarie, PhD

Principal Investigator

Laval University

Eligibility Criteria

This trial is for veterans suffering from chronic low back pain who have not found relief with conventional treatments. Participants should be open to combining non-invasive brain stimulation and new physiotherapy approaches.

Inclusion Criteria

High level of psychosocial factors, scoring ≥4 on the Start Back Screening Tool psychosocial subscale

I am between 18 and 65 years old.

I am a veteran with chronic low back pain.

Exclusion Criteria

Presenting with any specific rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, and pregnancy

Diagnosis of drug or alcohol abuse

My medication dose for pain or mental health hasn't changed in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week intervention program combining rTMS with PiP, PiP alone, or usual physiotherapy

8 weeks

5 visits (in-person) in weeks 1-2, 2 visits (in-person) per week in weeks 3-8

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 weeks

Follow-up assessments at weeks 2, 8, and 26

Treatment Details

Interventions

• Active rTMS
• Psychologically-informed physiotherapy (PiP)
• Sham rTMS

Trial Overview The study tests if repetitive transcranial magnetic stimulation (rTMS) can boost the benefits of psychologically-informed physiotherapy (PiP) compared to usual care for managing chronic low back pain in veterans.

Participant Groups

Group I: Active rTMS + PiP Experimental Treatment 2 Interventions

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.

Group II: Usual physiotherapy Active Control 1 Intervention

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.

Group III: Sham rTMS + PiP Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Chronic Pain Centre of Excellence for Canadian Veterans

Collaborator

Foundation for Physical Medicine and Rehabilitation

Collaborator

Trials

7

Recruited

240+