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

NARecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

June 11, 2025

Primary Completion Date

November 1, 2026

Study Completion Date

June 1, 2027

Conditions
Chronic Low-back Pain (cLBP)
Interventions
DEVICE

Active rTMS

A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). Stimulation parameters will be obtained by measuring the motor threshold of the first right interosseous muscle, then the rTMS intensity will be set at 110% of this motor threshold. High frequency (HF) rTMS consisting of 60 trains of 5 s at 10 Hz with 15 s intertrain intervals, for a total of 3000 pulses per session, will be used. The coil will be positioned over the left dorsolateral PFC using the BeamF3 methods.

DEVICE

Sham rTMS

A sham coil will be used (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS and will be located over the same area (dorso-lateral prefrontal cortex).

OTHER

Psychologically-informed physiotherapy (PiP)

Participants will receive 6 intervention sessions (45 min) over 6 weeks by a physiotherapist. The objective of this intervention is to identify biopsychosocial factors that may impede recovery and to address these factors within the physiotherapist's scope of practice. Physiotherapists will use strategies such as the establishment of common goals and therapeutic alliance, the use of behavior change model, motivational interview, education on pain neurophysiology, gradual exposure to movement and stress management strategies (e.g. breathing techniques). Participants allocated to PiP groups will have access to a website offering support information related to understanding their pain (e.g. pain neuroscience education), myths and false beliefs related to back pain, understanding the impact of psychological factors on their pain, self-management strategies, and healthy lifestyle habits. This site will be freely available to participants during the course of the study.

OTHER

Usual physiotherapy

Participants will receive 6 intervention sessions (45 min) over 8 weeks by a physiotherapist. This is a pragmatic group that aims to represent real-word clinical practice i.e. interventions commonly used in physiotherapy to manage CLBP. All interventions that a physiotherapist can deliver in the province of Quebec will be allowed (e.g. manual therapy, exercises). No training will be provided to better reflect usual clinical practice in physiotherapy.

Trial Locations (2)

G1M 2S8

RECRUITING

Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS), Québec

NOT_YET_RECRUITING

Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale), Québec

All Listed Sponsors
collaborator

Chronic Pain Centre of Excellence for Canadian Veterans

UNKNOWN

collaborator

Foundation for Physical Medicine and Rehabilitation

OTHER

lead

Laval University

OTHER