NCT05006066

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

July 21, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Temporal SummationMechanical StimulationHeat Pain StimulationThermode

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

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)

Other: Temporal Summation

Interventions

4 type of stimulations applied on the right arm

Healthy volunteers - Pain-Free

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Subjects aged 18 to 30 years, able to consent (understand English or French)
  • No chronic pain
  • No primary sensory disorders

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, JH1 5N4, Canada

RECRUITING

MeSH Terms

Interventions

Postsynaptic Potential Summation

Intervention Hierarchy (Ancestors)

Synaptic TransmissionSignal TransductionBiochemical PhenomenaChemical PhenomenaSynaptic PotentialsMembrane PotentialsCell Physiological PhenomenaElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Guillaume Léonard, Ph.D

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthieu Vincenot, MS.c

CONTACT

Guillaume Léonard, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 16, 2021

Study Start

July 12, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations