NCT05396820

Brief Summary

This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 18, 2022

Last Update Submit

May 14, 2024

Conditions

Keywords

kinesiophobiaexperimental paincorticospinal excitabilitymotor controlCUSOM

Outcome Measures

Primary Outcomes (2)

  • Corticospinal excitability

    It will be measured using transcranial magnetic stimulation at different intensities in order to model I/O curves for each participant. Measurements will be taken before (pain-free condition) and after (pain condition) the application of a patch of capsaicin 1%, at the shoulder. Electromyographic signals, induced by the magnetic stimuli, will be captured with surface electrodes glued to the skin the anterior deltoid and upper trapezius muscles. To facilitate obtaining deltoid MEPs, participants will be asked to voluntarily contract 8-12% of their maximum voluntary contraction. The Boltzmann sigmoidal function will be used to fit the data points to construct the I/O curves. The mathematical modeling of the I/O curves allows the calculation of three parameters: the slope, the plateau, and the S50, the intensity allowing to obtain a response twice less than the maximum response. These 3 parameters will be used to compare them with the 2 conditions (before and after pain).

    1 hour

  • Kinesiophobia

    Kinesiophobia will be assessed using the French-Canadian version of the Tampa Kinesiophobia Questionnaire (EKT-CF). It takes the form of a self-reported questionnaire of 17 items using a Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with an acceptable degree of internal consistency (Cronbach's alpha = 0.71), satisfactory construct validity, and high sensitivity to change (intra-class correlation coefficient \> 0.7). The total score is obtained by adding the value of the responses and is between 17 and 68. The value of 40/68 is considered as the threshold value at which kinesiophobia becomes significant.

    5 minutes

Secondary Outcomes (6)

  • Activation synergies

    1 hour

  • Kinematic parameters: Linearity of motion

    1 hour

  • Kinematic parameters: Smoothness of motion

    1 hour

  • Kinematic parameters: Maximum directional error

    1 hour

  • EMG data and cumulative summation: The area of the puffs

    1 hour

  • +1 more secondary outcomes

Study Arms (1)

Experimental pain

EXPERIMENTAL

Experimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral).

Other: Experimental pain

Interventions

Experimental pain will be induced by capsaicin 1% on intact, non-irritated and dry shoulder's skin. For the purposes of this study, we will remove this patch before the recommended application time in order to generate a pain. The participant will be seated on a chair facing a table so that his or her dominant forearm rests on the table. Markers will be placed at the table and chair legs as well as on the table, corresponding to the two support points of the elbow and the index finger, in order to standardize the starting position. The target of the pointing movement will be placed at 80% of this maximum distance. The investigator will tell the participant to stand by, and then, within 4 to 10 seconds, an audible signal will indicate to the subject that he/she should perform the pointing movement. The procedure will repeat after a 4-10 second pause. For each session, 30 pointing movements reaching the target will be performed.

Experimental pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects (who do not have self-reported neurological disorders)
  • Subjects who have signed an informed consent (who have a good command of French)
  • Subjects affiliated with or receiving social security benefits

You may not qualify if:

  • Psychiatric history obtained through physician questioning: individuals with mental retardation or severe impairment of cognitive, behavioral, or emotional function that precludes understanding the protocol and signing informed consent
  • Neurological history (epilepsy, stroke, surgeries performed on the brain or spinal cord, and history of neurological diseases affecting motor skills and sensation)
  • Subjects who are unable to receive informed information (dementia, hearing problems, poor French proficiency, etc.)
  • Contraindications to MST (epilepsy, intracranial metal foreign bodies, hearing aids or cochlear implants)
  • Taking psychotropic medications
  • Persons under guardianship or conservatorship
  • Pregnant and nursing women
  • Subjects with pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurasport

Loos, Nord, 59120, France

Location

Related Publications (1)

  • Duport A, Morel P, Leonard G, Devanne H. The influence of pain and kinesiophobia on motor control of the upper limb: how pointing task paradigms can point to new avenues of understanding. Pain. 2024 Sep 1;165(9):2044-2054. doi: 10.1097/j.pain.0000000000003213. Epub 2024 Mar 13.

MeSH Terms

Conditions

KinesiophobiaAcute Pain

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
A randomized number is allocated for all participants.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Cross sectional study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 31, 2022

Study Start

September 5, 2022

Primary Completion

October 28, 2022

Study Completion

October 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations