Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain

Laval University

Status: Enrolling

Conditions: Chronic Low-back Pain (cLBP)

Treatments: Other: Usual physiotherapy; Device: Active rTMS; Other: Psychologically-informed physiotherapy (PiP); Device: Sham rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06999772

2025-3215 : DLPFC - PiP

Details and patient eligibility

About

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.

Full description

The study will compare the effects of (1) combining rTMS with PiP, (2) PiP alone (+sham rTMS), and (3) usual physiotherapy (UP) on physical functioning in Veterans suffering from CLBP and comorbid psychological factors associated with back pain. Participants will undergo an 8-week intervention program. Validated questionnaires will be used to measure outcomes at baseline, 2-, 8-, and 26-week follow-ups. The main objective is to determine if the combination of PiP and rTMS is superior to PiP and UP alone to improve physical functioning in Veterans suffering from CLBP and comorbid psychological factors.

The secondary objectives are to compare the effectiveness of these interventions on secondary outcomes, that are, pain intensity, quality of life, movement pain-related fear, pain catastrophizing, self-efficacy, depression symptoms, medication use and post-traumatic stress disorder symptoms.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups

Active rTMS + PiP

Experimental group

Description:

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.

Treatment:

Other: Psychologically-informed physiotherapy (PiP)

Device: Active rTMS

Sham rTMS + PiP

Sham Comparator group

Description:

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.

Treatment:

Device: Sham rTMS

Other: Psychologically-informed physiotherapy (PiP)

Usual physiotherapy

Active Comparator group

Description:

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.

Treatment:

Other: Usual physiotherapy