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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332939
• Other study ID #: 2020-3273
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Université de Sherbrooke
• Contact: Guillaume Léonard, PhD. pht
• Phone: 1 819-780-2220
• Email: guillaume.leonard2[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• transcranial direct current stimulation
real tDCS sessions
• Physical exercise
Aerobic exercise and physical training combined with sham tDCS

Locations

Country	Name	City	State
Canada	Grace Village	Sherbrooke	Quebec
Canada	Research Centre on Aging	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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