Chronic PainNCT05370833
Transcranial Direct Current Stimulation in Clinical Setting to Reduce Pain in Older Workers
A study testing transcranial direct current stimulation in people with Chronic Pain and Aging, run by Université de Sherbrooke at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 years and older
- Conditions the study is for
- Chronic Pain, Aging
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 15 May 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be more than 55 years old
- To have chronic pain
- To have employment relationship
- To have pain that interferes with work tasks
Who cannot join
- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Clinique régionale de la gestion de la douleur - CISSSAT
Rouyn-Noranda, Quebec
Rodrigo Deamo, PhD
- Active, not recruiting
Centre de Recherche sur le Vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
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
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).
Read the 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).
- Conditions
- Chronic Pain, Aging
- Being tested
- transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, physical therapy, work retention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Anodal, 2mA, tDCS session applied on M1 for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard protocol | Experimental | 5 tDCS sessions in 1 week Receives: Device: transcranial direct current stimulation |
| Enhanced protocol | Experimental | 11 tDCS sessions devised in 4 weeks Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
0-10 Numerical rating scale
Measured: Before tDCS
Pain intensity
0-10 Numerical rating scale
Measured: 1 week
Pain intensity
0-10 Numerical rating scale
Measured: 4 weeks
Pain intensity
0-10 Numerical rating scale
Measured: 4 weeks after the last tDCS session
Disability
Pain Disability Index
Measured: Before tDCS
Disability
Pain Disability Index
Measured: 1 week
Disability
Pain Disability Index
Measured: 4 weeks
Disability
Pain Disability Index
Measured: 4 weeks after the last tDCS session
Work role functioning
Work Role Functioning Questionnaire
Measured: Before tDCS
Work role functioning
Work Role Functioning Questionnaire
Measured: 1 week
Work role functioning
Work Role Functioning Questionnaire
Measured: 4 weeks
Work role functioning
Work Role Functioning Questionnaire
Measured: 4 weeks after the last tDCS session
Physical Functioning
Brief Pain Inventory
Measured: Before tDCS
Physical Functioning
Brief Pain Inventory
Measured: 1 week
Physical Functioning
Brief Pain Inventory
Measured: 4 weeks
Physical Functioning
Brief Pain Inventory
Measured: 4 weeks after the last tDCS session
Anxiety
Beck anxiety inventory
Measured: Before tDCS
Anxiety
Beck anxiety inventory
Measured: 1 week
Anxiety
Beck anxiety inventory
Measured: 4 weeks
Anxiety
Beck anxiety inventory
Measured: 4 weeks after the last tDCS session
Depression
Beck depression inventory
Measured: Before tDCS
Depression
Beck depression inventory
Measured: 1 week
Depression
Beck depression inventory
Measured: 4 weeks
Depression
Beck depression inventory
Measured: 4 weeks after the last tDCS session
Impression of change
Patient Global impression of change
Measured: 1 week
Impression of change
Patient Global impression of change
Measured: 4 weeks
Impression of change
Patient Global impression of change
Measured: 4 weeks after the last tDCS session
Central sensitization
central sensitization inventory
Measured: Before tDCS
Central sensitization
central sensitization inventory
Measured: 1 week
Central sensitization
central sensitization inventory
Measured: 4 weeks
Central sensitization
central sensitization inventory
Measured: 4 weeks after the last tDCS session
Secondary outcomes (3)
Recruitment
Feasibility of the study
Measured: through study completion, about 2 years
Security
Feasibility of the study
Measured: through study completion, about 2 years
Intervention
Feasibility of the study
Measured: through study completion, about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start15 May 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- CISSS Abitibi-Témiscamingue
- Responsible party
- Principal investigator, Guillaume Léonard, Université de Sherbrooke
- Investigators
- Guillaume Leonard, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370833
- Sponsor's protocol ID
- MP-31-2022-4640
- Status last verified
- Jul 2023
- First submitted
- 11 Apr 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370833
- Acronym / sponsor ID
- MP-31-2022-4640
- Conditions
- Chronic Pain, Aging
- Keywords
- transcranial direct current stimulation, physical therapy, work retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- CISSS Abitibi-Témiscamingue
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard protocol | Experimental | Device: transcranial direct current stimulation5 tDCS sessions in 1 week |
| Enhanced protocol | Experimental | Device: transcranial direct current stimulation11 tDCS sessions devised in 4 weeks |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be more than 55 years old
- To have chronic pain
- To have employment relationship
- To have pain that interferes with work tasks
Key exclusion criteria (1 listed)
- tDCS contraindications (epilepsy, metallic implant in the head, pacemaker, cochlear implant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAnodal, 2mA, tDCS session applied on M1 for 20 minutes. | Device | Enhanced protocol, Standard protocol |
Primary outcome
Pain intensity
Time frame: Before tDCS
0-10 Numerical rating scale
Pain intensity
Time frame: 1 week
0-10 Numerical rating scale
Pain intensity
Time frame: 4 weeks
0-10 Numerical rating scale
Pain intensity
Time frame: 4 weeks after the last tDCS session
0-10 Numerical rating scale
Disability
Time frame: Before tDCS
Pain Disability Index
Disability
Time frame: 1 week
Pain Disability Index
Disability
Time frame: 4 weeks
Pain Disability Index
Disability
Time frame: 4 weeks after the last tDCS session
Pain Disability Index
Work role functioning
Time frame: Before tDCS
Work Role Functioning Questionnaire
Work role functioning
Time frame: 1 week
Work Role Functioning Questionnaire
Work role functioning
Time frame: 4 weeks
Work Role Functioning Questionnaire
Work role functioning
Time frame: 4 weeks after the last tDCS session
Work Role Functioning Questionnaire
Physical Functioning
Time frame: Before tDCS
Brief Pain Inventory
Physical Functioning
Time frame: 1 week
Brief Pain Inventory
Physical Functioning
Time frame: 4 weeks
Brief Pain Inventory
Physical Functioning
Time frame: 4 weeks after the last tDCS session
Brief Pain Inventory
Anxiety
Time frame: Before tDCS
Beck anxiety inventory
Anxiety
Time frame: 1 week
Beck anxiety inventory
Anxiety
Time frame: 4 weeks
Beck anxiety inventory
Anxiety
Time frame: 4 weeks after the last tDCS session
Beck anxiety inventory
Depression
Time frame: Before tDCS
Beck depression inventory
Depression
Time frame: 1 week
Beck depression inventory
Depression
Time frame: 4 weeks
Beck depression inventory
Depression
Time frame: 4 weeks after the last tDCS session
Beck depression inventory
Impression of change
Time frame: 1 week
Patient Global impression of change
Impression of change
Time frame: 4 weeks
Patient Global impression of change
Impression of change
Time frame: 4 weeks after the last tDCS session
Patient Global impression of change
Central sensitization
Time frame: Before tDCS
central sensitization inventory
Central sensitization
Time frame: 1 week
central sensitization inventory
Central sensitization
Time frame: 4 weeks
central sensitization inventory
Central sensitization
Time frame: 4 weeks after the last tDCS session
central sensitization inventory
3 secondary outcomes
Recruitment
Time frame: through study completion, about 2 years
Security
Time frame: through study completion, about 2 years
Intervention
Time frame: through study completion, about 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Yes. Upon request to the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Leonard, PhD principal investigator
Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Chronic Pain and Aging, run by Université de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Leonard, PhD (819-780-2220 ext. 45246, guillaume.leonard2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Before tDCS). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.