Chronic PainNCT04726423
Chronic Pain and Transcranial Direct Current Stimulation in Clinical Settings
An observational study of Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Physical exercises and transcranial direct current stimulation (tDCS) are both known to reduce chronic pain in structured laboratory studies. The aim of this study is to assess the efficacy of this combined treatment in clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- transcranial direct current stimulation
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2021to Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that received tDCS sessions in clinical settings
Who may be able to join
- To have chronic pain
Who cannot join
- Contraindication to tDCS
Trial locations and contacts
1 site in 1 country.
Marie-Philippe Harvey, M.Sc contact
Canada1 site, 1 recruiting
- Recruiting
Physio-Atlas
Sherbrooke, Quebec, J1L 0H8
Antoine Laramé, M.Sc., 819-562-0868
About this study
Official title: Reduce Chronic Pain With Transcranial Direct Current Stimulation in Clinical Settings
Physical exercises and transcranial direct current stimulation (tDCS) are both known to reduce chronic pain in structured laboratory studies. The aim of this study is to assess the efficacy of this combined treatment in clinical settings.
Read the detailed description
Chronic pain patients who are going to the physiotherapy clinic to receive tDCS treatment sessions are evaluated in order to assess the efficacy of tDCS in clinical settings. Physiotherapists prescribe physical exercises adapted to the patients conditions. Patients performed their physical exercises every time they received a tDCS treatment, but were also recommended to continue their physical exercises program at home after completion of physiotherapy visits.
Concerning tDCS treatment, patients were encouraged to receive 1 tDCS session per day for 5 consecutive days.
- Conditions
- Chronic Pain
- Being tested
- transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, physical exercise, physiotherapy, clinical settings
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
Also called tDCS
5 daily sessions of tDCS (2mA, 20 min) were recommended to all patients. Physical exercises were also done at the physiotherapy clinic. Physical exercises program was recommended to be continued at home after the week of physiotherapy visits.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in McGill pain Questionnaire
qualitative and quantitative aspects of pain
Measured: Baseline, 1 week, 1 month
Change in Brief Pain Inventory
Physical Function
Measured: Baseline, 1 week, 1 month
Change in Tampa Questionnaire
Kinesiophobia
Measured: Baseline, 1 week, 1 month
Change in Beck Depression Inventory
Depression
Measured: Baseline, 1 week, 1 month
Change in Patient global impression of change
Impression of change
Measured: 1 week, 1 month
Secondary outcomes (2)
Number of sessions received
Feasibility; did the patients received all their tDCS sessions in 5 days (1 per day)
Measured: Through study completion, an average of 5 days
Side effect
Side effect reported by the patients (headache, dizziness, fatigue, nausea, redness, tingling)
Measured: Through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Jan 2021
- Primary completion4 Feb 2021
- Study completionDec 2023 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- 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
- NCT04726423
- Sponsor's protocol ID
- 2020-3273-PA
- Status last verified
- Jul 2023
- First submitted
- 15 Jan 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Reduce Chronic Pain With Transcranial Direct Current Stimulation in Clinical Settings
- ClinicalTrials.gov ID
- NCT04726423
- Acronym / sponsor ID
- 2020-3273-PA
- Conditions
- Chronic Pain
- Keywords
- transcranial direct current stimulation, physical exercise, physiotherapy, clinical settings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jan 2021 (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.
Physical exercises and transcranial direct current stimulation (tDCS) are both known to reduce chronic pain in structured laboratory studies. The aim of this study is to assess the efficacy of this combined treatment in clinical settings.
Detailed description
Chronic pain patients who are going to the physiotherapy clinic to receive tDCS treatment sessions are evaluated in order to assess the efficacy of tDCS in clinical settings. Physiotherapists prescribe physical exercises adapted to the patients conditions. Patients performed their physical exercises every time they received a tDCS treatment, but were also recommended to continue their physical exercises program at home after completion of physiotherapy visits.
Concerning tDCS treatment, patients were encouraged to receive 1 tDCS session per day for 5 consecutive days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that received tDCS sessions in clinical settings
Key inclusion criteria (1 listed)
- To have chronic pain
Key exclusion criteria (1 listed)
- Contraindication to tDCS
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 stimulationAlso: tDCS5 daily sessions of tDCS (2mA, 20 min) were recommended to all patients. Physical exercises were also done at the physiotherapy clinic. Physical exercises program was recommended to be continued at home after the week of physiotherapy visits. | Other | – |
Primary outcome
Change in McGill pain Questionnaire
Time frame: Baseline, 1 week, 1 month
qualitative and quantitative aspects of pain
Change in Brief Pain Inventory
Time frame: Baseline, 1 week, 1 month
Physical Function
Change in Tampa Questionnaire
Time frame: Baseline, 1 week, 1 month
Kinesiophobia
Change in Beck Depression Inventory
Time frame: Baseline, 1 week, 1 month
Depression
Change in Patient global impression of change
Time frame: 1 week, 1 month
Impression of change
2 secondary outcomes
Number of sessions received
Time frame: Through study completion, an average of 5 days
Side effect
Time frame: Through study completion, an average of 5 days
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.
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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.
Marie-Philippe Harvey, M.Sc contact
Guillaume Leonard, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Université de Sherbrooke at 1 site 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 1 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 1 site 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 (1 819-780-2220, guillaume.leonard2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in McGill pain Questionnaire (time frame: Baseline, 1 week, 1 month). The study lists 5 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.