Clinical trial NCT04332939: Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly
Official title: Activating Motor System to Relieve Pain in Elderly: What is the Role of Physical Exercise and Transcranial Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: transcranial direct current stimulation
physical exercise
corticospinal projections
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Pain intensity
timeFrame: 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 outcomes:
measure: Corticospinal excitability (TMS)
timeFrame: Before intervention, Follow-up 1 week after, Follow-up 1 month after
measure: Corticospinal excitability (dMRI)
timeFrame: Before intervention, Follow-up 1 week after, Follow-up 1 month after
measure: Functional connectivity
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: McGill pain questionnaire
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Brief pain inventory
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Beck depression inventory
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Beck anxiety inventory
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Margolis pain drawing and scoring system
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Patient global impression of change questionnaire
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Tampa questionnaire
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
measure: Pain catastrophizing scale
timeFrame: Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging
state: Quebec
city: Sherbrooke
country: Canada
facility: Grace Village
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Guillaume Léonard, pht, PhD.
role: PRINCIPAL_INVESTIGATOR
References: