Pain, ChronictDCS-painNCT05617027
Relieving Chronic Pain in Older Adults With Transcranial Direct Current Stimulation
A study testing actual transcranial direct current stimulation (tDCS) in people with Pain, Chronic, run by Université de Sherbrooke at 3 sites in Canada.
Trial summary
The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- actual transcranial direct current stimulation (tDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- 19 Oct 2023to 1 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be aged ≥ 65 years
- Have chronic (≥ 6 months) musculoskeletal pain of moderate to severe intensity (≥4 out of 10 on a numerical scale of 0 to 10)
Who cannot join
- Those with contraindications to tDCS
- Those with contraindications to TMS
- Those with contraindications to IRM
- Individuals for whom the procedure could cause impairment of well-being, or has another medical condition that could put them at risk in the judgment of a health care professional.
- Patients taking medications that act on the GABAergic and glutamatergic systems (modulating tDCS effects) will be excluded
- Individuals taking other types of medications or receiving rehabilitation are not excluded but will be asked, in the absence of clinical contraindication, to avoid any modification (e.g., new treatment, discontinuation, or change in dose) during the study.
- People with epilepsy and seizures will not be excluded from the study. The research team will simply be asked to pay closer attention to these participants during the administration of MST.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Institut universitaire sur la réadaptation en déficience physique de Montréal (IURDPM)
Montreal, Quebec, H3S 2J4
Camille Proulx, M. Sc, erg., camille.proulx.1@umontreal.ca
Johanne Higgins, Ph. D
- Recruiting
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
Estelle Gouriou, Ph. D, 418-525-4444 ext. 47539, estelle.gouriou@crchudequebec.ulaval.ca
Cyril Schneider, Ph. D
- Recruiting
Centre de recherche sur le vieillissement (CdRV)
Sherbrooke, Quebec, J1H 4C4
Marie-Philippe Harvey, Ph.D., 819-821-8000 ext. 45080, marie.philippe.harvey@usherbrooke.ca
Guillaume Leonard, Ph.D., pht., 819-821-8000
About this study
The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. The real tDCS group will receive a daily 20-minute session of tDCS (current intensity = 2 mA), for 5 consecutive days, while the placebo tDCS group will receive an equivalent treatment, but the current will be stopped after the first 30 seconds. The study will take place in 5 rehabilitation clinics in 3 Quebec regions. One hundred and fifty (150) seniors aged 65 years or older with chronic (> 6 months), moderate to severe musculoskeletal pain will be recruited (50 participants/region). Follow-ups will take place at 1 week and 3 months post-treatment. The primary dependent variable is pain intensity (numerical scale from 0 to 10). Secondary variables will be measured using standardized and validated questionnaires: 1) pain-related interferences (physical function, mood, quality of life) and 2) perception of post-TDCS changes. Neurophysiological measures (pain control pathways).
Read the detailed description
Rationale : Chronic pain is the leading cause of disability and affects a large number of seniors. Transcranial direct current stimulation (tDCS), which provides non-invasive stimulation of the brain, is a promising avenue for relieving pain that is refractory to traditional treatments. To date, however, its clinical efficacy has yet to be confirmed in the elderly.
Objectives : The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. Secondary objectives are to assess the effect of tDCS on pain-related interference and the relationship between the response to tDCS and the integrity of pain control systems (descending pathways controlling pain circuits).
Methods : This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. The real tDCS group will receive a daily 20-minute session of tDCS (current intensity = 2 mA), for 5 consecutive days, while the placebo tDCS group will receive an equivalent treatment, but the current will be stopped after the first 30 seconds. The study will take place in 5 rehabilitation clinics in 3 Quebec regions: Sherbrooke (n=1), Quebec City (n=2), Montreal (n=2). One hundred and fifty (150) seniors aged 65 years or older with chronic (> 6 months), moderate to severe musculoskeletal pain will be recruited (50 participants/region). Follow-ups will take place at 1 week and 3 months post-treatment. The primary dependent variable is pain intensity (numerical scale from 0 to 10). Secondary variables will be measured using standardized and validated questionnaires: 1) pain-related interferences (physical function, mood, quality of life) and 2) perception of post-TDCS changes. Neurophysiological measures (pain control pathways), i.e., the integrity of corticothalamic and corticospinal projections will be tested by diffusion MRI and transcranial magnetic stimulation.
Anticipated results: Our hypotheses are that (i) real tDCS will be more effective in reducing pain intensity than placebo tDCS at 1 week post-treatment. This reduction in pain will be maintained at the 3-month post-treatment follow-up of real tDCS. (ii) Real tDCS will be more effective than placebo treatment in reducing pain interference with physical function, mood and quality of life. Perceived improvement with the treatment received will also be greater for real tDCS. (iii) Individuals with stronger cortico-thalamic and corticospinal projections in pre-tDCS will be more relieved by actual tDCS than those with less strong projections.
Ultimately, this study will allow us to evaluate the effectiveness of tDCS in the care setting for the relief of chronic musculoskeletal pain in the elderly and to identify those individuals most likely to respond to this type of treatment based on potential biomarkers related to the integrity of the pain control system.
- Conditions
- Pain, Chronic
- Being tested
- actual transcranial direct current stimulation (tDCS), placebo transcranial direct current stimulation (tDCS)
- Keywords
- Chronic pain, transcranial direct current stimulation, quality of life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
actual transcranial direct current stimulation (tDCS)Other
tDCS is a non-invasive brain stimulation technique that would influence the brain's pain control mechanisms.
The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA.
placebo transcranial direct current stimulation (tDCS)Other
The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA for 30 secondes, and then 0 mA for the rest of the 20-minute session.
| Study group | Role | What they receive |
|---|---|---|
| actual tDCS | Experimental | The actual transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of actual tDCS , 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session.
The tDCS current will be 2 mA for the whole 20-minute session. Receives: Other: actual transcranial direct current stimulation (tDCS) |
| placebo tDCS | Placebo comparator | The placebo transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of placebo tDCS, 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session.
The tDCS current will be 2 mA for 30 secondes, and then will strop for the rest of the 20-minute session (programming of the equipment). Receives: Other: placebo transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline to 1 week after the intervention
Visual analogue scale (0-10) where 0 = no pain, 10= worst pain
Measured: Mean of Patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention
Maintenance of the effect on pain after from to 1 week to 3 months after intervention
Visual analogue scale (0-10) where 0 = no pain, 10= worst pain
Measured: Mean of Patient reported pain on 5 consecutive days: 3 months after the intervention to see if the effect of the treatment is maintained.
Secondary outcomes (8)
Sociodemographic, life habits, and medical history data
Questionnaire including questions regarding age, sex, gender, education, salary, drug use, coffee, tobacco, alcohol, diagnosis, time since onset of symptoms, concomitant medication.
Measured: Selection visit (pre-intervention)
Change in affective component of pain from baseline to 1 week and 3 months after intervention
McGill-Melzack Questionnaire: The 20 questions in this tool focus on the qualitative aspect of pain, for a total of 78 points, and are divided into 4 subcategories: sensory, affective, evaluative and miscellaneous. Higher is the score, the greater is the pain.
Measured: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in mood from baseline to 1 week and 3 months after intervention
Hospital Anxiety and Depression Scale (HADS): 14-item questionnaire measured with a 4-point Likert scale (0 = no to 3 = yes, definitively). Higher score indicating higher distress.
Measured: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in physical function related to pain from baseline to 1 week and 3 months after intervention
Brief Pain Inventory - short form (BPI): this 9 item questionnaire is use to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. It uses a 0 to 10 numeric rating scales for item rating. The BPI has no scoring algorithm.
Measured: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in quality of life covering eight domains of health from baseline to 1 week and 3 months after intervention
36-Item Short Form Survey (SF-36): This questionnaire covers eight domains of health related to quality of life: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.
Measured: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in perception of change with treatment from 1 week to 3 months after intervention
Patient Global Impression of Change (PGIC). This questionnaire assesses perceived changes using a 7-point scale, ranging from "Significantly Worsened" to "Significantly Improved.
Measured: i. 1 week after the intervention, and ii. 3 months after the intervention
Neurophysiological measures (MRI, Tractography)
Magnetic resonance imaging (MRI) is an imaging test that uses powerful magnetic forces, radio waves and a computer to produce detailed 3-dimensional images of organs, bones and soft tissue inside your body. In this particular context, IRM will allow to quantify the integrity and morphology of myelinated corticospinal projection (in the brain) via a diffusion MRI and mathematical reconstruction of the tract (tractography analysis).
Measured: i. 1 week before the intervention
Functional neuroanatomical measurement (TMS)
Transcranial Magnetic Stimulation (TMS): allows the evaluation of corticospinal projections. This technique aims to stimulate certain nerve cells via short magnetic pulses directed to the brain.This stimulation release a potential.known as a motor evoked potential, MEP which is then recorded using electromyography (EMG). The magnitude of muscle activity generated for a given TMS pulse strength forms a measure of cortical excitability in the stimulated region.
Measured: i. 1 week before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start19 Oct 2023
- Primary completion15 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Model description
- Multicenter randomized controlled trial (RCT) with placebo that includes two parallel groups (real tDCS and placebo tDCS), with random assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Guillume Léonard, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617027
- Sponsor's protocol ID
- MP-31-2022-4641
- Acronym
- tDCS-pain
- Status last verified
- Jul 2024
- First submitted
- 25 Oct 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relieving Chronic Pain in Older Adults With Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT05617027
- Acronym / sponsor ID
- tDCS-pain / MP-31-2022-4641
- Conditions
- Pain, Chronic
- Keywords
- Chronic pain, transcranial direct current stimulation, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Nov 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.
The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. The real tDCS group will receive a daily 20-minute session of tDCS (current intensity = 2 mA), for 5 consecutive days, while the placebo tDCS group will receive an equivalent treatment, but the current will be stopped after the first 30 seconds. The study will take place in 5 rehabilitation clinics in 3 Quebec regions. One hundred and fifty (150) seniors aged 65 years or older with chronic (> 6 months), moderate to severe musculoskeletal pain will be recruited (50 participants/region). Follow-ups will take place at 1 week and 3 months post-treatment. The primary dependent variable is pain intensity (numerical scale from 0 to 10). Secondary variables will be measured using standardized and validated questionnaires: 1) pain-related interferences (physical function, mood, quality of life) and 2) perception of post-TDCS changes. Neurophysiological measures (pain control pathways).
Detailed description
Rationale : Chronic pain is the leading cause of disability and affects a large number of seniors. Transcranial direct current stimulation (tDCS), which provides non-invasive stimulation of the brain, is a promising avenue for relieving pain that is refractory to traditional treatments. To date, however, its clinical efficacy has yet to be confirmed in the elderly.
Objectives : The primary objective of this study is to determine, in a healthcare setting, the effectiveness of actual tDCS in reducing pain compared with placebo tDCS. Secondary objectives are to assess the effect of tDCS on pain-related interference and the relationship between the response to tDCS and the integrity of pain control systems (descending pathways controlling pain circuits).
Methods : This is a multicenter randomized controlled trial with parallel groups (real tDCS vs. placebo) blinded to participants, assessors and tDCS providers. The real tDCS group will receive a daily 20-minute session of tDCS (current intensity = 2 mA), for 5 consecutive days, while the placebo tDCS group will receive an equivalent treatment, but the current will be stopped after the first 30 seconds. The study will take place in 5 rehabilitation clinics in 3 Quebec regions: Sherbrooke (n=1), Quebec City (n=2), Montreal (n=2). One hundred and fifty (150) seniors aged 65 years or older with chronic (> 6 months), moderate to severe musculoskeletal pain will be recruited (50 participants/region). Follow-ups will take place at 1 week and 3 months post-treatment. The primary dependent variable is pain intensity (numerical scale from 0 to 10). Secondary variables will be measured using standardized and validated questionnaires: 1) pain-related interferences (physical function, mood, quality of life) and 2) perception of post-TDCS changes. Neurophysiological measures (pain control pathways), i.e., the integrity of corticothalamic and corticospinal projections will be tested by diffusion MRI and transcranial magnetic stimulation.
Anticipated results: Our hypotheses are that (i) real tDCS will be more effective in reducing pain intensity than placebo tDCS at 1 week post-treatment. This reduction in pain will be maintained at the 3-month post-treatment follow-up of real tDCS. (ii) Real tDCS will be more effective than placebo treatment in reducing pain interference with physical function, mood and quality of life. Perceived improvement with the treatment received will also be greater for real tDCS. (iii) Individuals with stronger cortico-thalamic and corticospinal projections in pre-tDCS will be more relieved by actual tDCS than those with less strong projections.
Ultimately, this study will allow us to evaluate the effectiveness of tDCS in the care setting for the relief of chronic musculoskeletal pain in the elderly and to identify those individuals most likely to respond to this type of treatment based on potential biomarkers related to the integrity of the pain control system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled trial (RCT) with placebo that includes two parallel groups (real tDCS and placebo tDCS), with random assignment
| Arm | Type | Receives |
|---|---|---|
| actual tDCS | Experimental | Other: actual transcranial direct current stimulation (tDCS)The actual transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of actual tDCS , 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session. The tDCS current will be 2 mA for the whole 20-minute session. |
| placebo tDCS | Placebo comparator | Other: placebo transcranial direct current stimulation (tDCS)The placebo transcranial direct current stimulation (tDCS) intervention will be conducted by a physiotherapist who will perform 5 sessions of placebo tDCS, 5 consecutive days, for 20 minutes of treatment for a total of 45 minutes at the clinic for each session. The tDCS current will be 2 mA for 30 secondes, and then will strop for the rest of the 20-minute session (programming of the equipment). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Be aged ≥ 65 years
- Have chronic (≥ 6 months) musculoskeletal pain of moderate to severe intensity (≥4 out of 10 on a numerical scale of 0 to 10)
Key exclusion criteria (7 listed)
- Those with contraindications to tDCS
- Those with contraindications to TMS
- Those with contraindications to IRM
- Individuals for whom the procedure could cause impairment of well-being, or has another medical condition that could put them at risk in the judgment of a health care professional.
- Patients taking medications that act on the GABAergic and glutamatergic systems (modulating tDCS effects) will be excluded
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 |
|---|---|---|
| actual transcranial direct current stimulation (tDCS)tDCS is a non-invasive brain stimulation technique that would influence the brain's pain control mechanisms. The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA. | Other | actual tDCS |
| placebo transcranial direct current stimulation (tDCS)The anode is attached to the skull above the M1 opposite the painful side (in case of unilateral pain) or opposite the dominant hand (in case of bilateral pain). The cathode (at the supraorbital level opposite the stimulated M1) will be positioned using the 10-20 EEG system and the tDCS intensity will be 2 mA for 30 secondes, and then 0 mA for the rest of the 20-minute session. | Other | placebo tDCS |
Primary outcome
Change in pain intensity from baseline to 1 week after the intervention
Time frame: Mean of Patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention
Visual analogue scale (0-10) where 0 = no pain, 10= worst pain
Maintenance of the effect on pain after from to 1 week to 3 months after intervention
Time frame: Mean of Patient reported pain on 5 consecutive days: 3 months after the intervention to see if the effect of the treatment is maintained.
Visual analogue scale (0-10) where 0 = no pain, 10= worst pain
8 secondary outcomes
Sociodemographic, life habits, and medical history data
Time frame: Selection visit (pre-intervention)
Change in affective component of pain from baseline to 1 week and 3 months after intervention
Time frame: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in mood from baseline to 1 week and 3 months after intervention
Time frame: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in physical function related to pain from baseline to 1 week and 3 months after intervention
Time frame: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in quality of life covering eight domains of health from baseline to 1 week and 3 months after intervention
Time frame: i. 1 week before the intervention, ii. 1 week after the intervention, and iii. 3 months after the intervention
Change in perception of change with treatment from 1 week to 3 months after intervention
Time frame: i. 1 week after the intervention, and ii. 3 months after the intervention
Neurophysiological measures (MRI, Tractography)
Time frame: i. 1 week before the intervention
Functional neuroanatomical measurement (TMS)
Time frame: i. 1 week before the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Guillume Léonard principal investigator
Université de Sherbrooke
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing actual transcranial direct current stimulation (tDCS) in people with Pain, Chronic, run by Université de Sherbrooke at 3 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 2 inclusion and 7 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 Marie-Philippe Harvey, Ph. D (819 821-8000 ext. 45082, marie.philippe.harvey@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity from baseline to 1 week after the intervention (time frame: Mean of Patient reported pain on 5 consecutive days: i. 1 week before the intervention compared to1 week after the intervention). The study lists 2 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 4 Mar 2025.