- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05006066
The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Matthieu Vincenot, MS.c
- Phone Number: 45682 819-780-2220
- Email: Matthieu.Vincenot@USherbrooke.ca
Study Contact Backup
- Name: Guillaume Léonard, Ph.D
- Phone Number: 72933 819-821-8000
- Email: Guillaume.Leonard2@USherbrook.ca
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, JH1 5N4
- Recruiting
- Université de Sherbrooke
-
Contact:
- Matthieu Vincenot, MS.c
- Phone Number: 45682 819-780-2220
- Email: Matthieu.Vincenot@USherbrooke.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects aged 18 to 30 years, able to consent (understand English or French)
- No chronic pain
- No primary sensory disorders
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy volunteers - Pain-Free
Each participant will be stimulated with 4 temporal summation stimulation conditions:
|
4 type of stimulations applied on the right arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During stimulation
|
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.
|
During stimulation
|
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.
|
During stimulation
|
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.
|
During stimulation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillaume Léonard, Ph.D, Université de Sherbrooke
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-4323
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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