Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| The Canadian Pain Society | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation alone and in combination with motor control exercises on pain and disability for patients with chronic non-specific low back pain.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS + Motor control exercises | Experimental | 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). |
|
| Sham rTMS + Motor control exercises | Sham Comparator | Sham 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 | Experimental | Active (real) repetitive transcranial magnetic stimulation (20 minutes). |
|
| Sham rTMS | Sham Comparator | Sham repetitive transcranial magnetic stimulation (20 minutes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (average pain over the last week) | Pain score on a 11-point pain numerical rating scale (PNRS) ranging from 0 to 10, with 0 meaning no pain and 10 the worst pain imaginable. | Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disability (ODI) | The Oswestry Disability Index (ODI) version 2.1 is a self-completed questionnaire giving a subjective percentage score of disability. Includes 10 questions rated on a 6-item scale, from 0 to 5 points. The total score ranges from "0" (No disability) to "100" (Maximal disability). | Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Brain imaging using MRI metrics | Resting-state fMRI and diffusion MRI imaging will be acquired on a 3T Philips Scanner (Achieva 3.0T (TX), Philips Healthcare Medical Systems, Best, Netherlands) with an 15-channel head coil. Functional and anatomic connection will be assessed between several regions of interest including: the primary motor cortex and the thalamus, the thalamus and the periaqueductal gray, the nucleus accumbens and the medial prefrontal cortex, the uncinate fasciculus. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hugo Massé-Alarie, PhD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale) | Québec | Quebec | G1M 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41385357 | Result | 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. | |
| 33762244 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Pseudo-factorial design (rTMS: Active/Sham | Exercises: Yes/No)
Not provided
Not provided
Participants will be masked to rTMS intervention (real or sham) but cannot be blinded to the exercise intervention. However, participants will not be aware of the study design (other arms).
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.
|
|
| Sham rTMS | Device | 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 | Other | 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. |
|
| Tampa scale of kinesiophobia (TSK) | TSK is used to assess pain-related fear of movement with a 17-item questionnaire. Each item is scored on a 4-point Likert scale. Total score ranges from 17 (minimal pain-related fear of movement) to 58 (maximal pain-related fear of movement). | Change from baseline to 8 weeks, 12 weeks and 24 weeks |
| Global rating of change | A 11-point scale ranging from -5 to 5, to evaluate the perceived change of health status after the intervention. | Change from baseline to 8 weeks |
| Baseline |
| 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. |