Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers
Primary Purpose
Chronic Pain, Aging
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring transcranial direct current stimulation, physical therapy, work retention
Eligibility Criteria
Inclusion Criteria:
- To be more than 55 years old
- To have chronic pain
- To have employment relationship
- To have pain that interferes with work tasks
Exclusion Criteria:
- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)
Sites / Locations
- Clinique régionale de la gestion de la douleur - CISSSATRecruiting
- Centre de Recherche sur le Vieillissement
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard protocol
Enhanced protocol
Arm Description
5 tDCS sessions in 1 week
11 tDCS sessions devised in 4 weeks
Outcomes
Primary Outcome Measures
Pain intensity
0-10 Numerical rating scale
Pain intensity
0-10 Numerical rating scale
Pain intensity
0-10 Numerical rating scale
Pain intensity
0-10 Numerical rating scale
Disability
Pain Disability Index
Disability
Pain Disability Index
Disability
Pain Disability Index
Disability
Pain Disability Index
Work role functioning
Work Role Functioning Questionnaire
Work role functioning
Work Role Functioning Questionnaire
Work role functioning
Work Role Functioning Questionnaire
Work role functioning
Work Role Functioning Questionnaire
Physical Functioning
Brief Pain Inventory
Physical Functioning
Brief Pain Inventory
Physical Functioning
Brief Pain Inventory
Physical Functioning
Brief Pain Inventory
Anxiety
Beck anxiety inventory
Anxiety
Beck anxiety inventory
Anxiety
Beck anxiety inventory
Anxiety
Beck anxiety inventory
Depression
Beck depression inventory
Depression
Beck depression inventory
Depression
Beck depression inventory
Depression
Beck depression inventory
Impression of change
Patient Global impression of change
Impression of change
Patient Global impression of change
Impression of change
Patient Global impression of change
Central sensitization
central sensitization inventory
Central sensitization
central sensitization inventory
Central sensitization
central sensitization inventory
Central sensitization
central sensitization inventory
Secondary Outcome Measures
Recruitment
Feasibility of the study
Security
Feasibility of the study
Intervention
Feasibility of the study
Full Information
NCT ID
NCT05370833
First Posted
April 11, 2022
Last Updated
July 10, 2023
Sponsor
Université de Sherbrooke
Collaborators
CISSS Abitibi-Témiscamingue
1. Study Identification
Unique Protocol Identification Number
NCT05370833
Brief Title
Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers
Official Title
Observation et Analyse Des Effets de la Stimulation transcrânienne à Courant Continu en Milieu Clinique Pour Soulager la Douleur Chronique Chez Les Travailleurs Vieillissants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
CISSS Abitibi-Témiscamingue
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
Chronic pain is one of the main factors influencing workers' retention at work. Considering that the prevalence of suffering from chronic pain increases with age, older workers are most likely to be absent from work because of their pain.
Transcranial direct current stimulation (tDCS) is a treatment option to reduce chronic pain.
This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).
Detailed Description
Chronic pain affects many spheres of the lives of affected individuals and those around them. In Canada, the prevalence of chronic pain is estimated at 15% of adults aged 18 and over. Among seniors, the prevalence of this health problem can reach up to 50% and affect one in two seniors. Chronic pain is one of the leading causes of work disability. In this context, pain reduction remains one of the most effective methods to enable the worker to stay at work. Considering the aging Quebec population, labor needs and the average retirement age which is increasingly postponed, it becomes crucial to take an interest in aging workers and their continued employment.
Transcranial direct current stimulation (tDCS) is a non-invasive neurostimulation method that has shown promise in reducing chronic pain. Recently, several research teams have shown that tDCS has beneficial effects on pain, physical function and social participation in seniors. Despite all these recent advances, very few studies have focused on optimizing tDCS treatment modalities and no studies have focused on the impact of tDCS on return to work or retention. The vast majority of studies using tDCS to reduce pain give one tDCS session per day for 5 consecutive days. This study aims to document the effect of tDCS on pain and work retention in older workers and to compare the traditional tDCS protocol (5 sessions) with an enhanced protocol (11 sessions).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Aging
Keywords
transcranial direct current stimulation, physical therapy, work retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard protocol
Arm Type
Experimental
Arm Description
5 tDCS sessions in 1 week
Arm Title
Enhanced protocol
Arm Type
Experimental
Arm Description
11 tDCS sessions devised in 4 weeks
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Anodal, 2mA, tDCS session applied on M1 for 20 minutes.
Primary Outcome Measure Information:
Title
Pain intensity
Description
0-10 Numerical rating scale
Time Frame
Before tDCS
Title
Pain intensity
Description
0-10 Numerical rating scale
Time Frame
1 week
Title
Pain intensity
Description
0-10 Numerical rating scale
Time Frame
4 weeks
Title
Pain intensity
Description
0-10 Numerical rating scale
Time Frame
4 weeks after the last tDCS session
Title
Disability
Description
Pain Disability Index
Time Frame
Before tDCS
Title
Disability
Description
Pain Disability Index
Time Frame
1 week
Title
Disability
Description
Pain Disability Index
Time Frame
4 weeks
Title
Disability
Description
Pain Disability Index
Time Frame
4 weeks after the last tDCS session
Title
Work role functioning
Description
Work Role Functioning Questionnaire
Time Frame
Before tDCS
Title
Work role functioning
Description
Work Role Functioning Questionnaire
Time Frame
1 week
Title
Work role functioning
Description
Work Role Functioning Questionnaire
Time Frame
4 weeks
Title
Work role functioning
Description
Work Role Functioning Questionnaire
Time Frame
4 weeks after the last tDCS session
Title
Physical Functioning
Description
Brief Pain Inventory
Time Frame
Before tDCS
Title
Physical Functioning
Description
Brief Pain Inventory
Time Frame
1 week
Title
Physical Functioning
Description
Brief Pain Inventory
Time Frame
4 weeks
Title
Physical Functioning
Description
Brief Pain Inventory
Time Frame
4 weeks after the last tDCS session
Title
Anxiety
Description
Beck anxiety inventory
Time Frame
Before tDCS
Title
Anxiety
Description
Beck anxiety inventory
Time Frame
1 week
Title
Anxiety
Description
Beck anxiety inventory
Time Frame
4 weeks
Title
Anxiety
Description
Beck anxiety inventory
Time Frame
4 weeks after the last tDCS session
Title
Depression
Description
Beck depression inventory
Time Frame
Before tDCS
Title
Depression
Description
Beck depression inventory
Time Frame
1 week
Title
Depression
Description
Beck depression inventory
Time Frame
4 weeks
Title
Depression
Description
Beck depression inventory
Time Frame
4 weeks after the last tDCS session
Title
Impression of change
Description
Patient Global impression of change
Time Frame
1 week
Title
Impression of change
Description
Patient Global impression of change
Time Frame
4 weeks
Title
Impression of change
Description
Patient Global impression of change
Time Frame
4 weeks after the last tDCS session
Title
Central sensitization
Description
central sensitization inventory
Time Frame
Before tDCS
Title
Central sensitization
Description
central sensitization inventory
Time Frame
1 week
Title
Central sensitization
Description
central sensitization inventory
Time Frame
4 weeks
Title
Central sensitization
Description
central sensitization inventory
Time Frame
4 weeks after the last tDCS session
Secondary Outcome Measure Information:
Title
Recruitment
Description
Feasibility of the study
Time Frame
through study completion, about 2 years
Title
Security
Description
Feasibility of the study
Time Frame
through study completion, about 2 years
Title
Intervention
Description
Feasibility of the study
Time Frame
through study completion, about 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be more than 55 years old
To have chronic pain
To have employment relationship
To have pain that interferes with work tasks
Exclusion Criteria:
- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Leonard, PhD
Phone
819-780-2220
Ext
45246
Email
guillaume.leonard2@usherbrooke.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Leonard, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique régionale de la gestion de la douleur - CISSSAT
City
Rouyn-Noranda
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Deamo, PhD
Facility Name
Centre de Recherche sur le Vieillissement
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request to the corresponding author
IPD Sharing Time Frame
Upon request
Learn more about this trial
Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers
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