HealthyNCT05006066
The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain
An observational study of Healthy, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Temporal summation is a mechanism that enhances pain perception. It is a natural mechanism present in most individuals. Generally, temporal summation is measured by the application of a moderately painful stimulation for several seconds.However, there is still no official recommendation in the literature. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Temporal Summation
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2021to 30 Aug 2022
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: For this project, healthy males and females (1:1 ratio) between the ages of 18 and 30 will represent our target population
Who may be able to join
- Subjects aged 18 to 30 years, able to consent (understand English or French)
- No chronic pain
- No primary sensory disorders
Who cannot join
- Presence of upper extremity injuries
- Absence of anxiety symptoms (HADs Score < 6) (Appendix 1)
- Presence of cardiovascular disease / neurocognitive disorders / mental illness
- Pregnant or postpartum women less than one year old
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec, JH1 5N4
Matthieu Vincenot, MS.c, 819-780-2220 ext. 45682, Matthieu.Vincenot@USherbrooke.ca
About this study
Temporal summation is a mechanism that enhances pain perception. It is a natural mechanism present in most individuals. Generally, temporal summation is measured by the application of a moderately painful stimulation for several seconds.However, there is still no official recommendation in the literature. There is therefore a great disparity in the protocols. Some studies apply thermal stimulation (heating the skin) while others apply mechanical stimulation (applying pressure). Another point of contention is that some studies apply continuous stimulation for 2 minutes while others apply a series of several small stimulation of 1 second). Between these studies, the amplitude of temporal summation varies according to the stimulation performed. Note also that the study population is also very different between studies. In these conditions, it remains difficult to know the impact of the nature of the stimulation on the measured amplitude of the temporal summation.
Read the detailed description
Objective: To determine the effect of the nature and frequency of the stimulation used to measure one of the physiological mechanisms of pain
Methods: In order to meet the objective, 34 pain-free participants will be recruited (17 females and 17 males) between the ages of 18 and 30 years. A single visit will be proposed (approximately 1 h). Each participant will be stimulated with 4 stimulation conditions:
- continuous thermal (1 stimulation of two minutes)
- repetitive thermal (30 stimulations of 1 second)
- continuous mechanical (1 stimulation of two minutes)
- repetitive mechanical (30 stimulation of 1 second) In order to control certain psychological parameters, questionnaires measuring anxiety, depression and fear of pain will be administered. This will allow the investigation team to perform subgroup analyses if necessary. A repeated measures analysis of variance will be performed to meet the objective.
Anticipated Results: The objective of this project is to determine the impact of different stimuli on the measurement of a pain mechanism. In this sense, the results will be important since they will allow to develop recommendations to optimize the measurement of this mechanism.
- Conditions
- Healthy
- Being tested
- Temporal Summation
- Keywords
- Temporal Summation, Mechanical Stimulation, Heat Pain Stimulation, Thermode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal SummationOther
4 type of stimulations applied on the right arm
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers - Pain-Free | Each participant will be stimulated with 4 temporal summation stimulation conditions:
* continuous thermal (1 stimulation of two minutes)
* repetitive thermal (30 stimulations of 1 second)
* continuous mechanical (1 stimulation of two minutes)
* repetitive mechanical (30 stimulation of 1 second) Receives: Other: Temporal Summation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal Summation of Pain - repetitive thermal stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Measured: During stimulation
Temporal Summation of Pain - continuous thermal stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Measured: During stimulation
Temporal Summation of Pain - continuous mechanical stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Measured: During stimulation
Temporal Summation of Pain - repetitive mechanical stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Measured: During stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start12 Jul 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 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
- Guillaume Léonard, Ph.D, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006066
- Sponsor's protocol ID
- 2022-4323
- Status last verified
- May 2022
- First submitted
- 21 Jul 2021
- Last updated
- 19 May 2022
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain
- ClinicalTrials.gov ID
- NCT05006066
- Acronym / sponsor ID
- 2022-4323
- Conditions
- Healthy
- Keywords
- Temporal Summation, Mechanical Stimulation, Heat Pain Stimulation, Thermode
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 16 Aug 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.
Temporal summation is a mechanism that enhances pain perception. It is a natural mechanism present in most individuals. Generally, temporal summation is measured by the application of a moderately painful stimulation for several seconds.However, there is still no official recommendation in the literature. There is therefore a great disparity in the protocols. Some studies apply thermal stimulation (heating the skin) while others apply mechanical stimulation (applying pressure). Another point of contention is that some studies apply continuous stimulation for 2 minutes while others apply a series of several small stimulation of 1 second). Between these studies, the amplitude of temporal summation varies according to the stimulation performed. Note also that the study population is also very different between studies. In these conditions, it remains difficult to know the impact of the nature of the stimulation on the measured amplitude of the temporal summation.
Detailed description
Objective: To determine the effect of the nature and frequency of the stimulation used to measure one of the physiological mechanisms of pain
Methods: In order to meet the objective, 34 pain-free participants will be recruited (17 females and 17 males) between the ages of 18 and 30 years. A single visit will be proposed (approximately 1 h). Each participant will be stimulated with 4 stimulation conditions:
- continuous thermal (1 stimulation of two minutes)
- repetitive thermal (30 stimulations of 1 second)
- continuous mechanical (1 stimulation of two minutes)
- repetitive mechanical (30 stimulation of 1 second) In order to control certain psychological parameters, questionnaires measuring anxiety, depression and fear of pain will be administered. This will allow the investigation team to perform subgroup analyses if necessary. A repeated measures analysis of variance will be performed to meet the objective.
Anticipated Results: The objective of this project is to determine the impact of different stimuli on the measurement of a pain mechanism. In this sense, the results will be important since they will allow to develop recommendations to optimize the measurement of this mechanism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers - Pain-Free | – | Other: Temporal SummationEach participant will be stimulated with 4 temporal summation stimulation conditions: * continuous thermal (1 stimulation of two minutes) * repetitive thermal (30 stimulations of 1 second) * continuous mechanical (1 stimulation of two minutes) * repetitive mechanical (30 stimulation of 1 second) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- For this project, healthy males and females (1:1 ratio) between the ages of 18 and 30 will represent our target population
Key inclusion criteria (3 listed)
- Subjects aged 18 to 30 years, able to consent (understand English or French)
- No chronic pain
- No primary sensory disorders
Key exclusion criteria (4 listed)
- Presence of upper extremity injuries
- Absence of anxiety symptoms (HADs Score < 6) (Appendix 1)
- Presence of cardiovascular disease / neurocognitive disorders / mental illness
- Pregnant or postpartum women less than one year old
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 |
|---|---|---|
| Temporal Summation4 type of stimulations applied on the right arm | Other | Healthy volunteers - Pain-Free |
Primary outcome
Temporal Summation of Pain - repetitive thermal stimulation
Time frame: During stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Temporal Summation of Pain - continuous thermal stimulation
Time frame: During stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Temporal Summation of Pain - continuous mechanical stimulation
Time frame: During stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Temporal Summation of Pain - repetitive mechanical stimulation
Time frame: During stimulation
Temporal Summation of pain referred to the change of pain perception during a painful stimulation. Temporal summation will be calculated by the difference in pain perception (on a 0-100 scale) and the beginning and at the end of each stimulation sequence. Temporal summation will be express as a percentage of increased.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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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 Léonard, Ph.D 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 Healthy, 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 3 inclusion and 4 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 19 May 2022. 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 Matthieu Vincenot, MS.c (819-780-2220 ext. 45682, Matthieu.Vincenot@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal Summation of Pain - repetitive thermal stimulation (time frame: During stimulation). The study lists 4 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 19 May 2022.