Chronic Low-back PainNCT04555278
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
A study testing Active rTMS in people with Chronic Low-back Pain, run by Hugo Massé-Alarie at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2020to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months";
- 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).
Who cannot join
- specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.);
- 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;
- presenting with any specific TMS/rTMS-related exclusion criteria such as previous seizure/convulsion, cochlear implant, specific medication and pregnancy;
- previous use of repetitive transcranial magnetic stimulation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
Québec, Quebec, G1M 2S8
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Alone and in Combination With Motor Control Exercise for the Treatment of Patients With Chronic Non-specific Low Back Pain (ExTraStim Trial): Study Protocol for a Randomized Controlled Trial
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Active rTMS, Sham rTMS, Motor Control Exercises
- Keywords
- Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Also called Repetitive Transcranial Magnetic Stimulation
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 rTMSDevice
Also called Sham Repetitive Transcranial Magnetic Stimulation
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Active rTMS; Other: Motor Control Exercises |
| 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). Receives: Device: Sham rTMS; Other: Motor Control Exercises |
| Active rTMS | Experimental | Active (real) repetitive transcranial magnetic stimulation (20 minutes). Receives: Device: Active rTMS |
| Sham rTMS | Sham comparator | Sham repetitive transcranial magnetic stimulation (20 minutes). Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Secondary outcomes (3)
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).
Measured: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
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).
Measured: 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.
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start25 Sep 2020
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pseudo-factorial design (rTMS: Active/Sham \| Exercises: Yes/No)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo Massé-Alarie
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Hugo Massé-Alarie, Laval University
- Investigators
- Hugo Massé-Alarie, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555278
- Sponsor's protocol ID
- 2020-1844
- Status last verified
- Jan 2026
- First submitted
- 14 Sep 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41385357Patricio 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.
PubMed 33762244
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Alone and in Combination With Motor Control Exercise for the Treatment of Patients With Chronic Non-specific Low Back Pain (ExTraStim Trial): Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04555278
- Acronym / sponsor ID
- 2020-1844
- Conditions
- Chronic Low-back Pain
- Keywords
- Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hugo Massé-AlarieUniversity, hospital or other
- Collaborators
- Pfizer, The Canadian Pain Society, Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Pseudo-factorial design (rTMS: Active/Sham | Exercises: Yes/No)
| Arm | Type | Receives |
|---|---|---|
| Active rTMS + Motor control exercises | Experimental | Device: Active rTMS, Other: Motor Control ExercisesActive (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 | Device: Sham rTMS, Other: Motor Control ExercisesSham 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 | Device: Active rTMSActive (real) repetitive transcranial magnetic stimulation (20 minutes). |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham repetitive transcranial magnetic stimulation (20 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic low back pain, defined as "pain in the low back area with or without leg pain above the knee limiting activities or daily routine which has been present for more than 3 months";
- 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).
Key exclusion criteria (7 listed)
- specific spinal pathology (fracture, tumor, radiculopathy, spinal infection, etc.);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active rTMSAlso: Repetitive Transcranial Magnetic StimulationA 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. | Device | Active rTMS, Active rTMS + Motor control exercises |
| Sham rTMSAlso: Sham Repetitive Transcranial Magnetic StimulationA 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). | Device | Sham rTMS, Sham rTMS + Motor control exercises |
| Motor Control ExercisesThe 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 | Active rTMS + Motor control exercises, Sham rTMS + Motor control exercises |
Primary outcome
Pain intensity (average pain over the last week)
Time frame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
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.
3 secondary outcomes
Disability (ODI)
Time frame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
Tampa scale of kinesiophobia (TSK)
Time frame: Change from baseline to 8 weeks, 12 weeks and 24 weeks
Global rating of change
Time frame: Change from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 41385357Patricio 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.
- Derived from this study: PubMed 33762244Patricio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Massé-Alarie, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Chronic Low-back Pain, run by Hugo Massé-Alarie at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (average pain over the last week) (time frame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.