The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain

May 17, 2022 updated by: Université de Sherbrooke
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Quebec
      • Sherbrooke, Quebec, Canada, JH1 5N4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For this project, healthy males and females (1:1 ratio) between the ages of 18 and 30 will represent our target 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillaume Léonard, Ph.D, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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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