Adaptation of the Motor System to Experimental Pain
KinesioPoint
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
1 active site
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
First Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
September 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedMay 16, 2024
May 1, 2024
2 months
May 18, 2022
May 14, 2024
Conditions
Keywords
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
EXPERIMENTALExperimental pain will be induced at the level of the dominant delto-pectoral groove of the participant (between the shoulder stump and the pectoral).
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.
Eligibility Criteria
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
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.
PMID: 38501987DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- 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