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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05006066
Other study ID # 2022-4323
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 12, 2021
Est. completion date August 30, 2022

Study information

Verified date May 2022
Source Université de Sherbrooke
Contact Matthieu Vincenot, MS.c
Phone 819-780-2220
Email Matthieu.Vincenot@USherbrooke.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Temporal Summation
4 type of stimulations applied on the right arm

Locations

Country Name City State
Canada Université de Sherbrooke Sherbrooke Quebec

Sponsors (2)

Lead Sponsor Collaborator
Université de Sherbrooke Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During stimulation
Primary 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. During stimulation
Primary 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. During stimulation
Primary 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. During stimulation
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