Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
transcranial direct current stimulation
Physical exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring transcranial direct current stimulation, physical exercise, corticospinal projections
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
Sites / Locations
- Research Centre on AgingRecruiting
- Grace VillageRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Exercise + real tDCS
Exercise + Sham tDCS
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Changes in Pain intensity
Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10
Secondary Outcome Measures
Corticospinal excitability (TMS)
Corticospinal tract excitability will be assessed with transcranial magnetic stimulation (TMS)
Corticospinal excitability (dMRI)
Corticospinal tract excitability will be assessed diffusion magnetic resonance imaging
Functional connectivity
Functional connectivity will be assessed with functional magnetic resonance imaging
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.
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
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
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
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
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
Tampa questionnaire
Tampa questionnaire will be used to assess pain in its globality. Score from 0 to 68, higher score means worse outcome
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
Full Information
NCT ID
NCT04332939
First Posted
January 23, 2020
Last Updated
March 24, 2023
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT04332939
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
transcranial direct current stimulation, physical exercise, corticospinal projections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise + real tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
Exercise + Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
real tDCS sessions
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
Aerobic exercise and physical training combined with sham tDCS
Primary Outcome Measure Information:
Title
Changes in Pain intensity
Description
Pain intensity will be assessed with a pain logbook containing a numerical rating scale from 0 to 10
Time Frame
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 Measure Information:
Title
Corticospinal excitability (TMS)
Description
Corticospinal tract excitability will be assessed with transcranial magnetic stimulation (TMS)
Time Frame
Before intervention, Follow-up 1 week after, Follow-up 1 month after
Title
Corticospinal excitability (dMRI)
Description
Corticospinal tract excitability will be assessed diffusion magnetic resonance imaging
Time Frame
Before intervention, Follow-up 1 week after, Follow-up 1 month after
Title
Functional connectivity
Description
Functional connectivity will be assessed with functional magnetic resonance imaging
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
McGill pain questionnaire
Description
McGill pain questionnaire will be used to assess pain in its globality. Score from 0 to 72, higher score means worse outcome.
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Brief pain inventory
Description
Brief pain inventory will be used to assess pain in its globality. Score from 0 to 70, higher score means worse outcome
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Beck depression inventory
Description
Beck depression inventory will be used to assess pain in its globality. Score from 0 to 39, higher score means worse outcome
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Beck anxiety inventory
Description
Beck anxiety inventory will be used to assess pain in its globality. Score from 0 to 63, higher score means worse outcome
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Margolis pain drawing and scoring system
Description
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
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Patient global impression of change questionnaire
Description
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
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Tampa questionnaire
Description
Tampa questionnaire will be used to assess pain in its globality. Score from 0 to 68, higher score means worse outcome
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
Title
Pain catastrophizing scale
Description
Pain catastrophizing scale will be used to assess pain in its globality. Score from 0 to 52, higher score means worse outcome
Time Frame
Before intervention, Follow-up 1 week after intervention, Follow-up 1 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Léonard, PhD. pht
Phone
1 819-780-2220
Ext
45246
Email
guillaume.leonard2@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Philippe HArvey, M.Sc
Phone
1 819-780-2220
Ext
45156
Email
marie.philippe.harvey@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Léonard, pht, PhD.
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre on Aging
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Léonard, pht, PhD
Phone
1 819-780-2220
Ext
45246
Email
guillaume.leonard2@usherbrooke.ca
Facility Name
Grace Village
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1M 0C6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Léonard, pht, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Motor System Activation With Transcranial Direct Current Stimulation and Physical Exercise to Reduce Pain in Elderly
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