Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
NCT ID: NCT04555278
Last Updated: 2026-01-20
Study Results
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2020-09-25
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Therapist delivering the exercise intervention will be masked to rTMS intervention (active vs. sham) but cannot be blinded to exercise intervention (yes vs. no).
Experimenter delivering the rTMS intervention will be masked to exercise intervention but not to rTMS intervention (real or sham).
Outcomes assessor will be completely masked to all interventions as all outcomes are questionnaires that will be completed online. Data will be de-identified and the data analyst will be masked to participants and group allocation.
Study Groups
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Active rTMS + Motor control exercises
Active (real) repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).
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). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT).
Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.
Motor Control Exercises
The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.
Sham rTMS + Motor control exercises
Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).
Sham rTMS
A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).
Motor Control Exercises
The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.
Active rTMS
Active (real) repetitive transcranial magnetic stimulation (20 minutes).
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). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT).
Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.
Sham rTMS
Sham repetitive transcranial magnetic stimulation (20 minutes).
Sham rTMS
A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).
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). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT).
Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.
Sham rTMS
A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).
Motor Control Exercises
The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* a minimal average pain intensity of 3 out of 10 during the preceding week on a pain numerical rating scale;
* a minimal score of 10 points on the Oswestry disability index (ODI).
Exclusion Criteria
* a history of back surgery;
* a major orthopedic, neurological, cardiovascular or psychiatric illness;
* low back pain is not the main pain complaint;
* currently using an exercise program to treat their LBP;
* previous use of repetitive transcranial magnetic stimulation.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
The Canadian Pain Society
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Hugo Massé-Alarie
OTHER
Responsible Party
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Hugo Massé-Alarie
Associate Professor, Medicine Faculty, Department of Rehabilitation
Principal Investigators
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Hugo Massé-Alarie, PhD
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, Canada
Countries
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References
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Patricio P, Tittley J, Lucas de Oliveira FC, Roy M, Fakhry N, Macedo LG, Hodges PW, Leonard G, Roy JS, Masse-Alarie H. Repetitive Transcranial Magnetic Stimulation and Motor Control Exercise for Chronic Low Back Pain: The ExTraStim Randomized Placebo-Controlled Trial. J Orthop Sports Phys Ther. 2026 Jan;56(1):1-10. doi: 10.2519/jospt.2025.13681.
Patricio P, Roy JS, Macedo L, Roy M, Leonard G, Hodges P, Masse-Alarie H. Repetitive transcranial magnetic stimulation alone and in combination with motor control exercise for the treatment of individuals with chronic non-specific low back pain (ExTraStim trial): study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e045504. doi: 10.1136/bmjopen-2020-045504.
Other Identifiers
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2020-1844
Identifier Type: -
Identifier Source: org_study_id
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