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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2027-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Low-back Pain (cLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Active rTMS

Intervention Type 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.

Psychologically-informed physiotherapy (PiP)

Intervention Type 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.

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.

Group Type SHAM_COMPARATOR

Sham rTMS

Intervention Type 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).

Psychologically-informed physiotherapy (PiP)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Usual physiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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).

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Repetitive Transcranial Magnetic Stimulation Sham Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No