Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Device: Active rTMS
* Device: Sham rTMS
* Other: Motor Control Exercises


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pseudo-factorial design (rTMS: Active/Sham | Exercises: Yes/No)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS + Motor control exercises<br>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). | Device: Active rTMS<br>* 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.<br>* Other names: Repetitive Transcranial Magnetic Stimulation;Other: Motor Control Exercises<br>* 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.<br>|
| Sham Comparator: Sham rTMS + Motor control exercises<br>Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes). | Device: Sham rTMS<br>* 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).<br>* Other names: Sham Repetitive Transcranial Magnetic Stimulation;Other: Motor Control Exercises<br>* 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.<br>|
| Experimental: Active rTMS<br>Active (real) repetitive transcranial magnetic stimulation (20 minutes). | Device: Active rTMS<br>* 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.<br>* Other names: Repetitive Transcranial Magnetic Stimulation;|
| Sham Comparator: Sham rTMS<br>Sham repetitive transcranial magnetic stimulation (20 minutes). | Device: Sham rTMS<br>* 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).<br>* Other names: Sham Repetitive Transcranial Magnetic Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 
| Quality of life (SF-12) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Motor Control Exercises, Randomized Controlled Trial