Recruiting

rTMS & PiP

Sponsor:

Laval University

Code:

NCT06999772

Conditions

Chronic Low-back Pain (cLBP)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active rTMS

Sham rTMS

Psychologically-informed physiotherapy (PiP)

Usual physiotherapy

Study Details

Brief 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.

Conditions

Chronic Low-back Pain (cLBP)

Study ID

NCT06999772

Start date

Jun 11, 2025

Status verified date

Jan, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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).

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.

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.

Primary outcome measure

  • Physical functioning (ODI) [ Time Frame: Baseline, weeks 2, 8 and 26. ]

Central Contacts and Locations

Central contacts

Hugo Massé-Alarie, PhD

(418) 529 9141hugo.masse-alarie@fmed.ulaval.ca

Locations

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

Recruiting

Québec, Quebec, Canada, G1M 2S8

Contacts

Hugo Massé-Alarie

418-529-9141hugo.masse-alarie@fmed.ulaval.ca

Jean Tittley

418-529-9141jean.tittley@cirris.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Non-invasive brain stimulation
  • comorbid psychological risk factors
  • chronic pain
  • repetitive transcranial magnetic stimulation
  • physiotherapy
  • pyschologically-informed
  • veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-01-20.