- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555278
Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe Patricio
- Phone Number: 418 529 9141
- Email: philippe.patricio.1@ulaval.ca
Study Contact Backup
- Name: Jean Tittley
- Phone Number: 581 308 5231
- Email: jean.tittley@cirris.ulaval.ca
Study Locations
-
-
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Québec, Canada, G1M 2S8
- CIRRIS (Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale)
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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.
Other Names:
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 Comparator: 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).
|
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.
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).
Other Names:
|
Experimental: Active rTMS
Active (real) repetitive transcranial magnetic stimulation (20 minutes).
|
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.
Other Names:
|
Sham Comparator: Sham rTMS
Sham repetitive transcranial magnetic stimulation (20 minutes).
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disability (ODI)
Time Frame: Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks
|
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
|
Tampa scale of kinesiophobia (TSK)
Time Frame: Change from baseline to 8 weeks, 12 weeks and 24 weeks
|
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
|
Quality of life (SF-12)
Time Frame: Change from baseline to 8 weeks, 12 weeks and 24 weeks
|
The SF-12 is a generic quality-of-life questionnaire which consist of twelve questions evaluating eight mental and physical health domains.
|
Change from baseline to 8 weeks, 12 weeks and 24 weeks
|
Global rating of change
Time Frame: Change from baseline to 8 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain imaging using MRI metrics
Time Frame: Baseline
|
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. |
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hugo Massé-Alarie, PhD, Laval University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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