Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly

Study Overview
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Brief Summary
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Physical exercises are known to reduce chronic pain in elderly individuals by activating the motor system. However, it seems that exercises are not effective for everyone. The investigators believe that elderly individuals with altered corticospinal tract will be those in whom the exercise alone are not sufficient to relieve pain. For those patients, adding an exogenous stimulation of the motor system such as transcranial direct current stimulation (tDCS) would facilitate the corticospinal tract, and consequently, would help exercises to relieve chronic pain. The investigators hypothesize that combining tDCS with the exercises will be more effective than exercises alone, but only in individuals who initially show low corticospinal projections.

Detailed Description
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Prevalence and intensity of chronic pain increases substantially with age. According to several studies, physical exercises are effective to reduce chronic pain in elderly. However, it seems that exercises are not effective for everyone. One of the hypotheses raised is that the people in whom the exercises have no effect would be those with an alteration of the corticospinal tract. Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique known to facilitate the corticospinal tract when applied over the motor cortex. Elderly suffering from chronic pain will be recruited in this double-blind, parallel-group, randomised control trial. Participants will be randomized to receive exercises combined to real tDCS (5 daily sessions, 2 mA, 20 minutes) or to sham tDCS. Intervention will last 8 weeks at a rate of 3 workouts per week.

Official Title
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Activating Motor System to Relieve Pain in Elderly: What is the Role of Physical Exercise and Transcranial Stimulation

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: transcranial direct current stimulation
* Other: Physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have musculoskeletal chronic pain Not to change medication and life habits during the study Exclusion Criteria: People physically active before the study (more then 150 min of moderate to vigorous exercise par week) To have an uncontrolled cardiovascular disease To have orthopedic limitation or contraindication to physical exercise To have contraindication to tDCS To have contraindication to TMS To have contraindication to MRI

Ages Eligible for Study
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Minimum Age: 60 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise + real tDCS<br>Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week. For the first week, participants will receive 5 daily sessions of anodal tDCS (2 mA, 20 min). | Other: transcranial direct current stimulation<br>* real tDCS sessions<br>Other: Physical exercise<br>* Aerobic exercise and physical training combined with sham tDCS<br>|
| Sham Comparator: Exercise + Sham tDCS<br>Intervention will last 8 weeks where participants will be trained at a rate of 3 workouts per week. For the first week, participants will receive 5 daily sessions of sham tDCS. | Other: Physical exercise<br>* Aerobic exercise and physical training combined with sham tDCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain intensity | Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10 | Before intervention (T1), First week of intervention (T2), Week 4 (T3), Week 8 (T4), Follow-up 1 week after intervention (T5), Follow-up 1 month after intervention (T6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticospinal excitability (TMS) | Corticospinal tract excitability will be assessed with transcranial magnetic stimulation (TMS) | Before intervention, Follow-up 1 week after, Follow-up 1 month after | 
| Corticospinal excitability (dMRI) | Corticospinal tract excitability will be assessed diffusion magnetic resonance imaging | Before intervention, Follow-up 1 week after, Follow-up 1 month after | 
| Functional connectivity | Functional connectivity will be assessed with functional magnetic resonance imaging | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| McGill pain questionnaire | McGill pain questionnaire will be used to assess pain in its globality. Score from 0 to 72, higher score means worse outcome. | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Brief pain inventory | Brief pain inventory will be used to assess pain in its globality. Score from 0 to 70, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Beck depression inventory | Beck depression inventory will be used to assess pain in its globality. Score from 0 to 39, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Beck anxiety inventory | Beck anxiety inventory will be used to assess pain in its globality. Score from 0 to 63, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Margolis pain drawing and scoring system | Margolis pain drawing and scoring system will be used to assess pain in its globality. Score from 0 to 45, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Patient global impression of change questionnaire | patient global impression of change questionnaire will be used to assess pain in its globality. Score from 0 to 18 and a percentage from 0 to 100. Higher scores mean better outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Tampa questionnaire | Tampa questionnaire will be used to assess pain in its globality. Score from 0 to 68, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 
| Pain catastrophizing scale | Pain catastrophizing scale will be used to assess pain in its globality. Score from 0 to 52, higher score means worse outcome | Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, physical exercise, corticospinal projections