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

Combining Non-invasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Other: Psychologically-informed physiotherapy (PiP); Device: Sham rTMS; Other: Usual physiotherapy; Device: Active rTMS

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hugo Massé-Alarie, PhD; Phone Number: 46642 (418) 529 9141; Email: hugo.masse-alarie@fmed.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1M 2S8
      • Recruiting
      • Centre interdisciplinaire de recherche en réadaptation et intégration sociale (CIRRIS)
      • Contact: Hugo Massé-Alarie; Phone Number: 6930 418-529-9141; Email: hugo.masse-alarie@fmed.ulaval.ca
      • Contact: Jean Tittley; Phone Number: 2478 418-529-9141; Email: jean.tittley@cirris.ulaval.ca
    • Québec, Quebec, Canada, G1M 2S8
      • Not yet recruiting
      • Cirris (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; 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.; Other Names: Repetitive Transcranial Magnetic Stimulation
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.	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.; 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 Names: Sham Repetitive Transcranial Magnetic Stimulation
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (NPRS)	The Numerical Pain Rating Scale (NPRS) is an 11-point scale used to measure the mean intensity of pain in the last week ranging from 0 (no pain) to 10 (worst imaginable pain).	Baseline, weeks 2, 8 and 26.
Pain catastrophizing (PCS)	The Pain Catastrophizing Scale (PCS) is a self-administrated questionnaire of 13 questions measuring catastrophizing thoughts contributing to pain on a 5-point scale ranging from 0 (not at all, low level of catastrophizing thoughts) to 5 (all the time, high level of catastrophizing thoughts).	Baseline, weeks 2, 8 and 26.
Fear of movement (TSK-13)	The Tampa Scale of Kinesiophobia is a self-administrated questionnaire used to assess fear of movement using 13 questions on a 4-point scale ranging from 1 (strongly disagree, low level of kinesiophobia) to 4 (strongly agree, high level of kinesiophobia).	Baseline, weeks 2, 8 and 26
Self-efficacy (PSEQ-10)	The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire mesuring the confidence people with ongoing pain have in performing activities while in pain, on a 10-point scale from 0 (not at all confident, low self-efficacy) to 10 (completely confident, high self-efficacy).	Baseline, weeks 2, 8 and 26.
Post-traumatic stress disorder (PCL-5)	The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item self-completed questionnaire that assesses the 20 DSM-5 symptoms of post-traumatic stress disorder on a 5-point scale ranging from 0 (not a all, no symptoms of PTSD) to 4 (extremely, severe symptoms of PTSD).	Baseline, weeks 2, 8 and 26.
Global rating of change (GRC)	The Global rating of change (GRC) is a 11-point scale ranging from -5 (a great deal worst) to 5 (a great deal better) to measure the perceived change of health status after the intervention.	Weeks 2, 8 and 26
Quality of life (EQ-5D-5L)	The EQ-5D-5L is a self-administrated questionnaire that contains 5 questions, each rated on a 5-point scale and mesuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions define 5^5 = 3125 possible health states, which can be converted into a Canadian weighted index score. This index score ranges from -0.148 (lowest value assigned to a health state) to 0.949 (highest value assigned to a health state).	Baseline, weeks 2, 8 and 26.
Depression symptoms (PHQ)	The Patient Health Questionnaire is a self-administrated questionnaire of 9 questions used to diagnose depression and grade severity of symptoms. The scale ranges from 0 to 27; a higher score means more depressive symptoms.	Baseline, weeks 2, 8 and 26.
Medication use	The Medication Quantification Scale Version 4 quantifies the risk weights of the use of 36 drug sub-classes used in pain management. Each drug sub-class has a detriment weight from 0 (low risk weight) to 10(high risk weight). The total score represents the summation of each drug class used by the participant.	Baseline, weeks 2, 8 and 26.
Patient Acceptable Symptom State (PASS)	The Patient Acceptable Symptom State (PASS) measures if the participants consider their current functional and symptoms states as satisfactory or not. A visual analogue scale ranging from 0 (completely dissatisfied) to 100 (completely satsified) is used.	Baseline, weeks 2, 8 and 26.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All adverse events and reasons for drop-out will be recorded and reported.	Weeks 2, and 8

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Foundation for Physical Medicine and Rehabilitation; Chronic Pain Centre of Excellence for Canadian Veterans
• Investigators: Principal Investigator: Hugo Massé-Alarie, PhD, Laval University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 31, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; physiotherapy; repetitive transcranial magnetic stimulation; veterans; Non-invasive brain stimulation; comorbid psychological risk factors; pyschologically-informed
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 2025-3215 : DLPFC - PiP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (IPD) that underlie the results reported in the published article will be made available. The study protocol will also be published.
• IPD Sharing Time Frame: Data will become accessible after the publication and will remain accessible for a period of 5 years after initial release.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No