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

NCT06999772 | Recruiting

• 1 other identifier: 2025-3215 : DLPFC - PiP
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Physical functioning (ODI)

  The Oswestry Disability Index (ODI) is a self-completed questionnaire on estimated disability including 10 questions rated on a 6-item scale, from 0 (no disability) to 5 points (maximal disability). The total score ranges from 0 (no disability) to 100% (maximal disability).

  Baseline, weeks 2, 8 and 26.

Secondary Outcomes (10)

• Pain intensity (NPRS)

  Baseline, weeks 2, 8 and 26.

• Quality of life (EQ-5D-5L)

  Baseline, weeks 2, 8 and 26.

• Depression symptoms (PHQ)

  Baseline, weeks 2, 8 and 26.

• Pain catastrophizing (PCS)

  Baseline, weeks 2, 8 and 26.

• Fear of movement (TSK-13)

  Baseline, weeks 2, 8 and 26

Other Outcomes (1)

• Adverse events

  Weeks 2, and 8

Study Arms (3)

Active rTMS + PiP

EXPERIMENTAL

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.

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

Sham rTMS + PiP

SHAM COMPARATOR

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.

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

Usual physiotherapy

ACTIVE COMPARATOR

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.

Other: Usual physiotherapy

Interventions

Active rTMS DEVICE

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.

Also known as: Repetitive Transcranial Magnetic Stimulation

Active rTMS + PiP

Sham rTMS DEVICE

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).

Also known as: Sham Repetitive Transcranial Magnetic Stimulation

Sham rTMS + PiP

Usual physiotherapy OTHER

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.

Usual physiotherapy

Psychologically-informed physiotherapy (PiP) OTHER

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.

Active rTMS + PiP; Sham rTMS + PiP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Foundation for Physical Medicine and Rehabilitation: collaborator
• Chronic Pain Centre of Excellence for Canadian Veterans: collaborator

Study Sites (2)

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

Québec, Quebec, G1M 2S8, Canada

RECRUITING

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

Québec, Quebec, G1M 2S8, Canada

NOT YET RECRUITING

Related Publications (1)

• Dupuis F, Tousignant-Laflamme Y, Marier Deschenes P, Fournier P, Nduwimana I, Ballot O, Loisel L, Pinard AM, Lacombe L, Langevin P, Gaumond A, Roy JS, Masse-Alarie H. Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 26;15:e78952. doi: 10.2196/78952.

  PMID: 41587077 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Hugo Massé-Alarie, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Massé-Alarie, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The masking depends on the intervention: For rTMS, participants, treating physiotherapists and the statistician will be blinded to the group allocation. It is not possible to blind the rTMS technician because they need to choose the right TMS coil and muscle twitches in the face is elicited by the active rTMS. For physiotherapy, it is only possible to blind the statistician. Although the outcomes assessors are not blinded per se, the use of REDcap limits the possibility of bias related to outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single-blind, parallel-group, monocentric, randomised controlled trial (RCT).

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become accessible after the publication and will remain accessible for a period of 5 years after initial release.
• Access Criteria: Access to IPD will be granted to qualified researchers whose proposals are methodologically sound and ethically approved. Researchers must obtain approval from their Institutional Review Board (IRB), Research Ethics Board (REB), or equivalent ethics committee, and must sign a Data Use Agreement (DUA) before receiving any data. Requests for access should be submitted to: hugo.masse-alarie@fmed.ulaval.ca.

Locations

CA (2)